1713 Pharmacovigilance Jobs

Summary Location: Hyderabad In this role, he will drive a strategic AI transformation across the pharmaceutical value chain, from drug discovery to commercialization, by leading enterprise-wide initiatives and coaching sub-ordinates to deliver high-impact solutions. About the Role Major Accountabilities Domain Expertise: Serve as a strategic expert in life sciences, providing leadership in applying Generative AI to drug discovery, clinical trials, regulatory affairs, pharmacovigilance, and market access. Drive thought leadership by identifying and promoting innovative Generative AI applications to position the organization as an industry leader. Business Analysis: Lead enterprise-wide initiatives to gather, analyze, and prioritize business requirements, aligning AI solutions with long-term organizational objectives. Oversee comprehensive analyses of complex business processes, designing AI-driven strategies to achieve operational excellence and competitive advantage. Authorize and review business cases, feasibility studies, and ROI analyses to secure executive approval for transformative AI initiatives. Ensure the creation of high-quality business requirements documents, process flows, and strategic roadmaps to guide enterprise-level AI implementations. Stakeholder Engagement: Act as a key liaison between C-suite executives, technical teams, and external partners, driving alignment on AI strategies and initiatives. Lead enterprise-level workshops, steering committees, and governance boards to shape AI adoption and ensure stakeholder buy-in. Represent the organization in industry forums and partnerships to advocate for AI-driven innovation in life sciences. Team Management and Coaching: Manage/mentor a team of Senior Specialist Business Analysts, providing strategic guidance, setting performance goals, and fostering professional development to ensure high-impact AI business use case delivery. Coach Senior Specialists in advanced business analysis techniques and Generative AI applications, enhancing their ability to address complex challenges in the life sciences domain and ensuring alignment with organizational objectives. Generative AI: Oversee the development and deployment of enterprise-scale Generative AI solutions, ensuring alignment with business needs and technical feasibility.s Collaborate with AI architects and data science leaders to define model architectures and deployment frameworks for life sciences applications. Ensure AI solutions are scalable, reliable, and fully integrated into mission-critical workflows. Regulatory & Compliance: Establish governance frameworks to ensure AI solutions comply with global regulatory standards (e.g., USFDA, EU, PMDA) and ethical principles. Lead risk management efforts, addressing ethical, legal, and operational risks associated with AI deployment in life sciences. Minimum Requirements 10–12 years of core Business Analyst or strategic consulting experience in the life sciences domain with at least 5 years leading AI technologies, supported by a Master’s degree in Life Sciences, Biomedical Sciences, Computer Science, Data Science, or a related field. A PhD or MBA is highly desirable. Expert understanding of Generative AI, machine learning, and their applications in life sciences. Proficiency in advanced data analysis tools (e.g., Python, TensorFlow, Power BI). Exceptional project management skills, with a proven track record of leading enterprise-scale AI projects (e.g., Agile, SAFe, or PMI methodologies). Superior analytical and problem-solving abilities, with a strategic mindset and ability to drive organizational change. Outstanding communication and leadership skills, with the ability to influence C-level stakeholders and lead cross-functional teams. Deep familiarity with life sciences/pharmaceutical regulatory requirements and industry standards. Why consider Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Division Operations Business Unit Universal Hierarchy Node Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Technology Transformation Job Type Full time Employment Type Regular Shift Work No

Company Description IACR Research Institute offers live, engaging, and interactive sessions, unlike other institutions in India that provide recorded sessions. Our approach allows students to clear their doubts with expert trainers. We focus on soft-skills training and personal development to help students overcome stage fear, self-confidence, and communication issues. Our team of experienced trainers regularly assesses students to identify difficulties and ensure they gain 100% technical knowledge. With a passion for training, our trainers guide clinical research aspirants to meet industry expectations and excel in their careers. Role Description This is a part-time on-site role for a Pharmacovigilance Offline Trainer located in Hyderabad. The Pharmacovigilance Trainer will conduct engaging and interactive training sessions, assessing students' understanding and providing comprehensive feedback. Responsibilities include creating training materials, conducting assessments, mentoring students, and guiding them through personal and professional development. The trainer will also stay updated with industry standards and best practices to ensure students are well-prepared for the competitive job market. Qualifications Experience in Pharmacovigilance and Clinical Research Ability to create effective training materials and conduct assessments Strong mentoring, coaching, and communication skills Expertise in soft-skills development and personal growth Excellent written and verbal communication skills Passion for training and a commitment to student success Proficiency in industry standards and best practices Master’s degree or equivalent in a relevant field preferred Prior teaching or training experience is a plus Job Types: Full-time, Part-time Pay: ₹12,000.00 - ₹15,000.00 per month Expected hours: No less than 10 per week Benefits: Cell phone reimbursement Schedule: Day shift Morning shift Language: English (Preferred) Work Location: In person

Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists in medical aspects of drug safety Provide medical advice/input for narratives written for Clinical Study Reports (CSRs) General: Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, clients guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Training and mentoring new team member, as required Working as Subject Matter Experts (SMEs) Assisting the Manager for inspection readiness activities and audits Provides inputs for process improvisations Works closely with Manger for process co-ordination and to ensure meeting all KPIs for the process. Case report Medical Review Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to DSPs and case processing team Literature review (as applicable) Review of literature for product safety assessment and potential safety issues Skills: Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge and Experience: 2 Years Relevant experience in Pharmacovigilance/ drug safety is desirable. Education: MBBS/Post Graduation in Medicine with relevant PV experience. #LI-REMOTE

Job Description As a pioneer in Healthcare, Manipal Hospitals is among the top healthcare providers in India serving over 5 million patients annually. Today we stand as an integrated network with a pan-India footprint of 37 hospitals across 19 cities with 10,500 beds, and a talented pool of over 5,600 doctors and an employee strength of over 20,000. Role: Associate -Clinical Pharmacist Location: Dwarka, Delhi What You'll Do: Conduct medication reviews and assessments to ensure appropriate pharmacotherapy for patients. Collaborate with physicians and healthcare teams to develop individualized treatment plans. Provide drug information and education to patients and healthcare staff regarding medication use, dosing, and side effects. Monitor patient responses to therapy and make recommendations for therapy adjustments as necessary. Participate in clinical rounds, case conferences, and interdisciplinary meetings to advocate for safe medication practices. Conduct therapeutic drug monitoring and adjust medications based on clinical guidelines and patient needs. Participate in the development and implementation of pharmacy-related policies and protocols. Stay updated with the latest advancements in pharmacotherapy and clinical guidelines. Mentor and train junior staff and pharmacy students as required. Ensure compliance with regulatory requirements and quality assurance standards. What We Are Looking For: Doctor of Pharmacy (Pharm.D.) or equivalent degree from an accredited institution. Active Pharmacy license in the practicing state. Previous experience in a clinical pharmacy setting is preferred. Strong knowledge of pharmacology, therapeutics, and medication management. Excellent communication and interpersonal skills. Ability to work collaboratively in a multidisciplinary team environment. Strong analytical and problem-solving skills. What We Offer: Competitive salary and benefits package Opportunities for professional development and career growth A collaborative and inclusive work environment Mandatory Skills Pharmacovigilance, Clinical Research, Clinical Data Management, Clinical Operations Location Delhi Roles & Responsibilities As a pioneer in Healthcare, Manipal Hospitals is among the top healthcare providers in India serving over 5 million patients annually. Today we stand as an integrated network with a pan-India footprint of 37 hospitals across 19 cities with 10,500 beds, and a talented pool of over 5,600 doctors and an employee strength of over 20,000.

Why Patients Need You Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Position Purpose The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc.), responses to regulatory queries on safety topics, post-marketing safety assessments, and Risk Management Plans and relevant documents. Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents. Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues. Provide oversight for internal or external (contractor) co-authors when required for a particular project or assignment (e.g., Canadian Annual Report). Qualification Requirement (i.e., Preferred Education, Experience, Attributes) Education: Bachelor's Degree in life sciences and 3+ years’ relevant medical experience such as, patient care, clinical trial experience / investigator, academic medicine, specialty training or pharmaceutical industry experience, ideally in safety, regulatory or clinical areas Advanced degree preferred (MD, DVM, PharmD, or Master’s/PhD in relevant field) Experience and Attributes: Able to execute routine analyses and interpret routine safety analyses with guidance from team members (analytic skills) Has comprehensive understanding of regulatory guidance as it pertains to presentation and communication of benefit/risk and pharmacovigilance (regulatory knowledge) Is able to synthesize analyses of aggregate or individual patient data into clearly written text with minimal supervision. (writing skills) Has good understanding of medical concepts of the disease and the specific approach to treatment. Makes decisions that require choosing between multiple options to resolve moderately complex problems, some of which deviate from standard situations. (analytic skills, and maybe interpersonal skills as well) Work Location Assignment: On Premise Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical

We are Hiring for “Diabetes Educator “ !!!! Company Name: Kartavya Healtheon Pvt Ltd. Website: http://kartavyahealtheon.com Location -Bhuj & Bharuch Contact Number: +91 77009 05394 Experience: -01 - 03 Yrs. Company Overview: Kartavya Healtheon is a Mumbai-based B2B healthcare company that drives patient engagement models. Our services include organizing in-clinic camps, running patient support programs, and operating specialty pharmacy services. Our mission is to make healthcare accessible to everyone, regardless of their location. We are currently running a program on behalf of one of our pharma clients to provide diabetes education and support to patients. As part of this program, we are looking for a skilled and compassionate Diabetes Educator to join our team. Job Overview : The Diabetes Educator will be responsible for educating patients with diabetes on how to manage their condition effectively. The Diabetes Educator will be responsible for Set of Doctors' clinics and hospitals handle OPD to provide patient education, counselling, queries resolution, program enrolment, pen demonstration, and guiding patients to the nearest pen station. The ideal candidate will have excellent communication and interpersonal skills, be able to work independently, and have a passion for helping patients with diabetes manage their condition. Responsibilities: Handle Set of Doctors' OPD clinics and hospitals to provide patient education, counselling, and support for diabetes management. Conduct pen demonstrations for patients. Develop a rapport with patients by responding to their queries and concerns. Guide patients to the approved pen stations. Follow up with patients to check on therapy initiation and support them in resolving any challenges. Enrol patients into the program by capturing patient details in the CRM system. Maintain a database of patients to ensure timely follow-up and support. Organize camps and patient support initiatives with doctors. Report on pharmacovigilance and implementation of compliance guidelines to ensure patient safety. Provide feedback to the Reporting Manager. Requirements: Science graduate or qualified dietician with 1 to 2 years of experience in Pharma or allied services or diet counselling or certified diabetic educator. Passion for working in the field and helping patients manage their diabetes. Excellent communication and interpersonal skills Ability to work independently and manage time effectively Ability to work flexible hours, including evenings and weekends if required Willingness to learn and a positive attitude with a pleasing personality Working Conditions: The Diabetes Educator will work in a variety of settings, including doctors' clinics and hospitals. They must be able to work flexible hours, including weekends and holidays. Note: The Diabetes Educator position is being offered as part of a program on behalf of one of our pharma clients, and the selected candidate will be hired by our company. Thanks & Regards,

Kenvue is currently recruiting for a: Senior Specialist Global Pharmacovigilance System Operations What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. Role reports to: AD Safety Analytics and Systems Location: Asia Pacific, India, Maharashtra, Greater Mumbai Work Location: Hybrid What you will do Travel %: 10% Pay: (If compliant with country’s laws) What you will do The Senior Specialist, Global PV System Operations is responsible for supporting the Associate Director, Safety Analytics and Systems in the maintenance of Pharmacovigilance (PV) System Operations and partner with Information Technology (internal and vendor teams) on the implementation of new systems, maintenance of existing systems, applicable interfaces and providing support to users for the vendor supported systems. Key Responsibilities Responsible for system activities performed by vendor including but not limited to Argus analytics, set-up of Reporting rules (RRs), product additions, protocol configurations, and MedDRA/system upgrades to enable safety reporting in compliance with local regulatory requirements and/or third-party agreement requirements. Supervises activities performed by vendors by monitoring daily metrics including training metrics. Plays a key role in team meetings and daily liaison with the vendor team to identify and resolve support desk issues. Provide guidance and support to clarify procedures (e.g. training) to ensure compliance relating to support of reporting rules for Business Partners and Health Authorities. Contribute and Participate in Change Control process User Acceptance Testing (UAT) activities for vendor supported systems and Kenvue supported systems. Liaise with staff in GMSO (Global Medical Safety Operations) function and other external functions as appropriate to facilitate compliant, timely and efficient case processing and reporting activities including electronic (E2B) or manual reporting of Individual Case Safety Reports (ICSRs) to Regulatory Authorities, Business Partners, Ethics Committees and investigators in accordance with Worldwide Safety Regulations, corporate and regulatory guidance documents, corporate policies, and/or third-party agreements. Assist Manager/Associate Director in CAPA management and/or provide oversight to investigations, assigned CAPAs, Task Actions, Effectiveness Checks and associated documentation ensuring documentation accuracy, compliance with completion timelines, and inspection ready state of all documentation. Participate in audits and inspections regarding system operational activities associated with Global PV Systems Operations activities or other scopes as identified. Accountable for the development and implementation of Standard Operating Procedures (SOPs)/Work Instructions (WIs) relating to distribution rules set up and electronic reporting of safety information. Oversee vendor training and development activities. Maintain 100% compliance in all assigned training and maintain knowledge of department policies and procedures. What we are looking for Required Qualifications BA or BSc degree in health-related field or other related scientific degree/qualification. Broad knowledge of pharmacovigilance with experience in inbound case receipt, regulatory reporting, case processing and other areas of PV. Previous industry experience with a focus on consumer safety related areas. Typically demonstrated by a minimum of 5-8 years’ industry experience. Previous industry experience with system implementation. Ability to independently make decisions and understand complexities of Kenvue products and Adverse Event categories in order to properly establish accurate queries. Problem solving abilities to handle electronic and distribution rules issues and escalate when appropriate. Excellent verbal, written and presentation skills. Desired Qualifications: Previous Computer Systems Business Validation experience. Previous experience in Oracle ARGUS Safety including reporting rules and company product dictionary. What’s in it for you Competitive Benefit Package* Paid Company Holidays, Paid Vacation, Volunteer Time & More! Learning & Development Opportunities Kenvuer Impact Networks This list could vary based on location/region Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process. Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Job Title: Life Sphere Multi Vigilance (LSMV) Service Delivery Manager Location: Pune, India Job Type: Full-time Mission: As the LSMV Service Delivery Manager, you are accountable for the design, delivery, and continuous improvement of services for Drug Safety System (Life Sphere Multi Vigilance) technology products. Your mission is to enable Roche to make and deliver quality pharmaceutical products effectively and efficiently. What You’ll Be Working On: Service Ownership: Own every aspect of the service delivery, governance, and performance Lead the resolution of incidents and problems, ensuring timely and effective solutions Perform complex root cause analysis and implement preventive measures to avoid issue recurrence Collaboration and Escalation: Collaborate with business leaders to establish fit-for-purpose quality services and act as an escalation point for major issues Work with Product Managers and business leaders to ensure releases and changes are delivered in a controlled and compliant manner Continuous Improvement: Drive continuous improvements to facilitate 'good enough' team output and elevate the overall service experience Implement and continuously mature DevOps practices Leadership and Mentorship: Act as an IT System Owner for multiple safety applications Act as an IT Product Owner and partner with Product Managers to manage application roadmaps Participate in large/global cross-functional squads, taking a leading role and mentoring colleagues Lead service delivery teams composed of internal and external third-party partners to achieve fit-for-purpose service levels in productivity, quality, output, and cost Audit and Compliance: Lead and serve as the IT Point of Contact for inspections and audits, ensuring processes are designed and updated with audits and compliance in mind Ensure the company's audit readiness and support inspection activities Security: Oversee the implementation of data security measures to protect sensitive and critical information from unauthorized access, breaches, and other vulnerabilities Stakeholder Communication: Communicate effectively with external partners and vendors to optimize service delivery and performance Team Collaboration: Foster good collaboration across projects and functional groups and between IT and business Role model teamwork and drive good collaboration practices within the team Ideal Candidate Characteristics: Domain Knowledge: Deep understanding of Drug Safety Systems (Life Sphere Multi Vigilance) Strong knowledge of ITIL and best practices for IT Service Management (ITSM) Business domain expertise in the pharmacovigilance industry, safety, and risk management areas Experience: 12+ years of experience in a Service Delivery Manager or equivalent role providing mission-critical services in a global organization 4+ years of experience handling pharmacovigilance inspections and audits Proven experience working with IT and Business Senior Leaders in a global environment Project management and release management experience Hands-on experience with DevOps and CI/CD environments Skills and Attributes: Strong stakeholder management and communication skills Solid system ownership skills that keep systems aligned with business needs and regulatory requirements Passion for learning, sharing, and developing best practices Result-driven and capable of achieving effective outcomes with an agile mindset Positive attitude, high energy, and exceptional cross-group collaboration skills Combination of analytical thinking, hands-on problem-solving, and a customer-service mindset Requirements: Bachelor’s degree in Computer Science, Information Systems, or a related field (or equivalent project-related experience) ITIL V3/V4 certification (preferably) Experience in Computer Systems Validation (CSV) Knowledge and awareness of regulations like HIPAA, GDPR, FDA CFR Part 11 Experience in highly regulated industries, preferably Life Sciences Ability to support global initiatives, programs, and projects and coordinate their implementation at the site level Flexibility to participate in virtual meetings outside normal hours and respond to escalations for major incidents Knowledge of the Scaled Agile Framework (SAFe) is a plus Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

Job title : Manager – Business Analytics Grade: L2-2 Location: Hyderabad % of travel expected: As per business need Job type: Permanent, Full time About The Job As part of GTMC, Insights & Analytics Capabilities delivers best-in-class and transformative insights and innovative tools and methods that actionably fuel Sanofi’s strategic business decisions, processes and deliverables. In doing so, our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department (Commercial & Medical) and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? Overall Purpose at Sanofi , we leverage analytics and technology to benefit patients worldwide. We seek individuals passionate about using data, analytics, and insights to drive decision-making and tackle global health threats. Our mission is to transform decision-making across our end-to-end commercialization process, from business development to late lifecycle management. The Manager – Business Analytics will provide deliverables that support planning and decision-making across multiple functional areas, such as finance, manufacturing, product development, medical and commercial. This role ensures high-quality deliverables, drives synergies across franchises, fosters innovation, and creates scalable, shareable solutions. Key Responsibilities Lead a team of business analyst and specialists with different level of expertise Coaches and develops business analyst and specialists (on dashboards, contents, methods, processes) Ensure compliance to regulatory requirements for activities supported Secure delivery of activities in time and in compliance with internal and external standards Participate in planning of analysis and data presentation to be used Keep abreast of industry and across industry best practices for Analytical solution Design solutions to bring efficiencies to the processes People Maintain effectiveness relationships with the stakeholders (Medical community, Digital, Commercial) within the allocated Global business unit and product – with an end objective to deliver as per requirement Interact effectively with stakeholders on medical and pharmacovigilance departments Constantly assist business analytics team in developing knowledge and sharing expertise Actively lead and develop SBO operations associates and ensure new technologies are leveraged Collaborate with global stakeholders for project planning and setting up the timelines and maintaining budget Performance Indicators : Feedback from (end stakeholders) on overall satisfaction Weightage : 20% Performance Oversee various process across GBUs activities, are supported as per agreed timelines and quality Works with other teams to leverage the cross-functional synergies Independently develops reports and collaborate with OneCI -Digital tower initiative for Medical activity reporting and support other enterprise level systems. Partner with Digital team to support: Data Management : Follow best practices to manage data including classification/Taxonomy of data, organization of and accelerating data gathering. Implement and fine-tune data governance guidelines, policies, processes, and controls. Data Quality : Defines data quality rules and implement automated monitoring, reporting, and remediation solutions Visualization : Collaborate with Digital team on development of BI dashboards around Medical activities. Participate in global, regional, and local meetings as relevant to better understand the business context and appropriately translate into deliverables Analyze data to address key business objectives and develop impactful dashboards/deliverables to report insights and recommendations. Synthesize insights from multiple reports to support business decisions and provide evidence-based recommendations. Communicate effectively with internal stakeholders and present key insights and recommendations. Provide evidence-based recommendations to support decision-making Performance indicator s : Adherence to timeline, quality target Works with other teams to leverage the cross-functional synergies Process Identifies and resolves operational issues, clearly articulate potential recommendations/solutions to local or global managers/partners Provides quality control (data, dashboards, process flows) and guidance in methodologies, processes, and SOPs Use methodologies and partner with internal teams to continuously improve data quality and availability by building business processes that support global standardization Identify inconsistencies in how data is being reported across teams and countries Ability to work cross-functionally, gather requirements, analyse data, and generate insights and reports that can be used by the GBU Ensure high standards for outputs and adherence to compliance procedures and internal/operational risk controls. Regularly refresh reports, dashboards, ETLs and conduct quality checks using the latest tools, technologies, and methodologies. Work cross-functionally to gather requirements, analyze data, and generate actionable insights and reports. Performance indicators: Feedback from stakeholders on satisfaction with deliverables Adherence to plan/calendar Weightage: 20% Stakeholders Work closely with medical teams in regions/areas to identify medical team needs and assist in developing assigned deliverables/dashboards Liaise with Medical department to ensure relevant & customized are delivered per expectation Defend gathered intelligence, methodology, content, and conclusions to global leadership in a clear, concise format. Performance indicator s: Adherence to timeline, quality target Weightage : 10% About You Experience: 8+ years of work experience in the fields of information science, data/database management, reporting data quality metrics Experience in a healthcare industry is a strong plus Soft skills: Excellent written and verbal communications skills with demonstrated ability to convey critical and sensitive information in a highly professional manner Technical skills: Ability to analyze large and complex datasets using statistical techniques and tools such as Excel, SQL, R, or Python. Proficiency in creating visually compelling and informative dashboards and reports using tools like Tableau, Power BI, or Qliksense to communicate insights effectively. Knowledge of data warehousing principles and experience in data cleansing, transformation, and integration to ensure data quality and consistency. Familiarity with tools like Power BI, Qlik sense, SQL, or Snowflake to extract, analyze, and present data for decision-making purposes. Strong organizational skills and the ability to manage multiple projects simultaneously, set priorities, allocate resources, and meet project deadlines. Excellent verbal and written communication skills to effectively communicate complex data insights to non-technical stakeholders and collaborate with cross-functional teams. Strong analytical and problem-solving skills to identify patterns, trends, and opportunities in healthcare data, as well as the ability to think critically and provide actionable recommendations based on findings. Education: Advance (Bachelor’s/Master’s) degree in Information Science, Computer Science, Mathematics, Statistics or a quantitative discipline in science, business, or social science. Experience in a healthcare industry is a strong plus Languages: Excellent knowledge in English and strong communication skills – written and spoken Why chose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Play an instrumental part in creating best practice within our Go-to-Market Capabilities. Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Summary Collection of data and generation of insights which demonstrate transformation impact. About The Role Major Responsibilities : Collaborate to elicit, document and analyse business information for the transformation and the Transformation Office. Responsible to support collection of Transformation related data from multiple sources accurately and efficiently to create a solid foundation for informed decision making. Responsible to enable the PV Transformation Office to develop strategy via high-quality and comprehensive data analysis of the collected data. Gatekeeper responsible for daily operationalisation of Transformation related Key Performance Indicators (KPIs) which are important to drive partnership and roadmap influence with strategic PV IT vendors and Development/ASCEND leadership. Defining and gathering robust data and evidence to build compelling business cases relating to Transformation. Assist the Transformation Office in monitoring workstream progress against milestones, ensuring adherence to timelines, budgets and scope Develop and maintain comprehensive Transformation Office documentation, archiving and operations Minimum Requirements Graduate/ Postgraduate in 5-7 years of industry experience Strong collaboration skills Data-driven way of working. Excellent analytical skills Experience in Pharmacovigilance is desirable Past experience working in large project environments Ability to deal with ambiguity Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Experience: 2-5years Key Responsibilities: Review and interpret physician orders and prescriptions for accuracy. Counsel patients on proper use, dosage, and side effects of medications. Monitor patient responses to medications and adjust treatment plans accordingly. Collaborate with doctors, nurses, and other healthcare professionals to ensure optimal patient outcomes. Maintain accurate records of prescriptions and inventory. Participate in ward rounds and clinical discussions. Ensure compliance with all regulatory and safety standards. Educate healthcare staff on drug updates and protocols. Assist in pharmacovigilance and report adverse drug reactions. Support antimicrobial stewardship programs. revive plus hospital hyd moti nagar hyd 500072 phone no:-8317535714 thank you... Job Type: Full-time Pay: ₹30,000.00 - ₹50,000.00 per month Benefits: Commuter assistance Work Location: In person

Title: Senior Study Data Manager Grade: L2-1 About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Join our Hyderabad Hub, build a career and you can be part of transforming our business while helping to change millions of lives. Ready? Within the Clinical Trial Team (CTT), the Senior Study Data Manager is responsible for leading the end-to-end Clinical Data Management (CDM) activities and study deliverables supporting study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. He/She is accountable for the quality of CDM deliverables and for ensuring accurate and reliable study data, therefore guaranteeing the reliability of the study results. He/She ensures activities are completed according to agreed standards and timelines. He/She provides comprehensive CDM expertise and supports team members by coordinating cross functional data related activities globally to ensure the flawless conduct of a clinical trial. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main responsibilities include: Accountability for the quality of CDM deliverables (such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports/Visualizations) and for the delivery of accurate and reliable clinical study data. Liaising directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc.) to coordinate all CDM activities for studies, discussing timelines, and providing CDM updates. Proactively anticipating and remediating CDM issues arising during study conduct and monitoring them until resolution. Defining and implementing data cleaning & validation strategy integrating risk-based approaches. Contributing to the protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, and other review activities during the conduct of a study. Leading study activities with internal and external (e.g., Providers) CDM delivery teams (Database Developers, Data Management Programmers, Central Monitors, etc.) and mentoring new Study Data Managers. Coordinating all external data activities: specifications, loading and reconciliation, including data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, and mobile healthcare. About you Experience: Experience on clinical data management of which, must have been in a project management role. Soft Skills: Project management skills and experience. Anticipate delivery risks. Learn and adapt quickly when facing new problems. Good interpersonal, communication, and presentation skills. Technical skills: Experience with CDM and related regulations (incl. ICH E6 and E8). Risk-based mindset focusing on Quality by Design (QbD) and on what really matters. Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations is a plus Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Join an international innovative biopharma company. Participate in the evolution of Clinical Data Management and deployment of innovations.

Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main responsibilities: Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews. Essential Job duties and responsibilities: 1) Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Reviews content created by peers’ writers. 4) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned. People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality Process: 1) Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. 6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. 7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8) Remain abreast of Sanofi Policy or Quality Documents evolution. Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables. About you Experience : >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality Technical skills : As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications ) Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT ) as per agreed timelines and quality Languages : Excellent knowledge of the English language (to read, write, and speak)

Responsible for research and authoring of scientific response documents under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Responsible for the execution of activities as required in alignment with GMI colleagues. Achieved through a combination of product knowledge, along with editing, writing, and document management proficiency. Essential Job duties and responsibilities: 1) Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature. 2) Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in designated therapeutic area(s). 3) Adapts global scientific response documents for assigned countries. 4) Develops responses to escalated inquiries for assigned countries. 5) Develops contributions to US NDA Annual Reports. 6) Contributes to US compendia reviews. 7) Contributes to peer reviews. 8) Demonstrates resolve and urgency to accomplish tasks without direct authority or control. Participate in cross-functional project teams as needed. Ensure that assigned projects are completed on schedule. 9) Develops and maintains Therapeutic Area expertise. 10) Reviews the content created by peer writers. 11) Collaborates effectively with Global Medical Information teams to execute content plans People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical information content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical information writers in developing knowledge and sharing expertise. Performance: Provide deliverables (scientific response documents, US NDA Annual Reports, US compendia reviews) as per agreed timelines and quality Process: 1) Act as an expert in the field of medical information writing and maintain on the regulatory requirement for countries supported. 2) Assist the assigned medical information team in conducting a comprehensive medical writing needs analysis. 3) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables.

Job title : Manager – Business Analytics Grade: L2-2 Location: Hyderabad % of travel expected: As per business need Job type: Permanent, Full time About the job As part of GTMC, Insights & Analytics Capabilities delivers best-in-class and transformative insights and innovative tools and methods that actionably fuel Sanofi’s strategic business decisions, processes and deliverables. In doing so, our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department (Commercial & Medical) and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? Overall Purpose at Sanofi , we leverage analytics and technology to benefit patients worldwide. We seek individuals passionate about using data, analytics, and insights to drive decision-making and tackle global health threats. Our mission is to transform decision-making across our end-to-end commercialization process, from business development to late lifecycle management. The Manager – Business Analytics will provide deliverables that support planning and decision-making across multiple functional areas, such as finance, manufacturing, product development, medical and commercial. This role ensures high-quality deliverables, drives synergies across franchises, fosters innovation, and creates scalable, shareable solutions. Key Responsibilities: Lead a team of business analyst and specialists with different level of expertise Coaches and develops business analyst and specialists (on dashboards, contents, methods, processes) Ensure compliance to regulatory requirements for activities supported Secure delivery of activities in time and in compliance with internal and external standards Participate in planning of analysis and data presentation to be used Keep abreast of industry and across industry best practices for Analytical solution Design solutions to bring efficiencies to the processes People Maintain effectiveness relationships with the stakeholders (Medical community, Digital, Commercial) within the allocated Global business unit and product – with an end objective to deliver as per requirement Interact effectively with stakeholders on medical and pharmacovigilance departments Constantly assist business analytics team in developing knowledge and sharing expertise Actively lead and develop SBO operations associates and ensure new technologies are leveraged Collaborate with global stakeholders for project planning and setting up the timelines and maintaining budget Performance Indicators : Feedback from (end stakeholders) on overall satisfaction Weightage : 20% Performance Oversee various process across GBUs activities, are supported as per agreed timelines and quality Works with other teams to leverage the cross-functional synergies Independently develops reports and collaborate with OneCI -Digital tower initiative for Medical activity reporting and support other enterprise level systems. Partner with Digital team to support: Data Management : Follow best practices to manage data including classification/Taxonomy of data, organization of and accelerating data gathering. Implement and fine-tune data governance guidelines, policies, processes, and controls. Data Quality : Defines data quality rules and implement automated monitoring, reporting, and remediation solutions Visualization : Collaborate with Digital team on development of BI dashboards around Medical activities. Participate in global, regional, and local meetings as relevant to better understand the business context and appropriately translate into deliverables Analyze data to address key business objectives and develop impactful dashboards/deliverables to report insights and recommendations. Synthesize insights from multiple reports to support business decisions and provide evidence-based recommendations. Communicate effectively with internal stakeholders and present key insights and recommendations. Provide evidence-based recommendations to support decision-making Performance indicator s : Adherence to timeline, quality target Works with other teams to leverage the cross-functional synergies Process Identifies and resolves operational issues, clearly articulate potential recommendations/solutions to local or global managers/partners Provides quality control (data, dashboards, process flows) and guidance in methodologies, processes, and SOPs Use methodologies and partner with internal teams to continuously improve data quality and availability by building business processes that support global standardization Identify inconsistencies in how data is being reported across teams and countries Ability to work cross-functionally, gather requirements, analyse data, and generate insights and reports that can be used by the GBU Ensure high standards for outputs and adherence to compliance procedures and internal/operational risk controls. Regularly refresh reports, dashboards, ETLs and conduct quality checks using the latest tools, technologies, and methodologies. Work cross-functionally to gather requirements, analyze data, and generate actionable insights and reports. Performance indicators : Feedback from stakeholders on satisfaction with deliverables Adherence to plan/calendar Weightage : 20% Stakeholders Work closely with medical teams in regions/areas to identify medical team needs and assist in developing assigned deliverables/dashboards Liaise with Medical department to ensure relevant & customized are delivered per expectation Defend gathered intelligence, methodology, content, and conclusions to global leadership in a clear, concise format. Performance indicator s: Adherence to timeline, quality target Weightage : 10% About you Experience : 8+ years of work experience in the fields of information science, data/database management, reporting data quality metrics Experience in a healthcare industry is a strong plus Soft skills : Excellent written and verbal communications skills with demonstrated ability to convey critical and sensitive information in a highly professional manner Technical skills : Ability to analyze large and complex datasets using statistical techniques and tools such as Excel, SQL, R, or Python. Proficiency in creating visually compelling and informative dashboards and reports using tools like Tableau, Power BI, or Qliksense to communicate insights effectively. Knowledge of data warehousing principles and experience in data cleansing, transformation, and integration to ensure data quality and consistency. Familiarity with tools like Power BI, Qlik sense, SQL, or Snowflake to extract, analyze, and present data for decision-making purposes. Strong organizational skills and the ability to manage multiple projects simultaneously, set priorities, allocate resources, and meet project deadlines. Excellent verbal and written communication skills to effectively communicate complex data insights to non-technical stakeholders and collaborate with cross-functional teams. Strong analytical and problem-solving skills to identify patterns, trends, and opportunities in healthcare data, as well as the ability to think critically and provide actionable recommendations based on findings. Education : Advance (Bachelor’s/Master’s) degree in Information Science, Computer Science, Mathematics, Statistics or a quantitative discipline in science, business, or social science. Experience in a healthcare industry is a strong plus Languages : Excellent knowledge in English and strong communication skills – written and spoken Why chose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Play an instrumental part in creating best practice within our Go-to-Market Capabilities. Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Summary Responsible for defining the strategy for Aggregate Reports & Risk Management (AR&RM) in the short and medium term (1 to 5 years) to ensure there is an ongoing cycle of assessment, innovation, and improvement with the aim of achieving high quality deliverables in a cost-effective manner with special attention to implementing automation and ESP solutions. Represents AR&RM in projects of strategic value for the future of PS&PV. About The Role Major accountabilities: Responsible for defining the strategy for AR&RM in partnership with the Head AR&RM Office & Strategy and in collaboration with stakeholders from other functions in PS&PV (Medical Safety, Process Excellence and Governance & Risk, QPPV, and others) and Development (RA, GMA, Clinical functions…), and from cross functional boards (GPTs). Responsible for assessing current capacities and capabilities of the AR&RM team and forecasting future needs for short to medium term maintaining the appropriate balance inhouse vs external for cost efficiency and quality. Responsible -in collaboration with the concerned team and Process Excellence and Governance & Risk - for exploring initiatives to streamline operations for process and quality improvement. When identified and approved, the person becomes responsible for successful execution of plans Responsible for contributing to and leading integration initiatives across aggregate reports (DSUR, PSUR, US PSR), risk management plans (RMPs), and implementation of RMPs in alignment with Development and PS&PV objectives and priorities Accountable for exploring new opportunities to develop and promote implementation of Artificial Intelligence solutions and other advanced tools to simplify and facilitate core activities of the AR&RM team. Seeks automation where possible in order to improve efficiency and productivity. This person or a delegate from his/her team will be the point of contact and/or main stakeholder representing the team in any automation project. Accountable for establishing close collaboration and alignment with internal PS&PV stakeholders (e.g., Medical Safety, Medical Safety Operations, Countries and Regions, QPPV Office, Process Excellence and Governance & Risk) to ensure their feedback is an important driver for the strategic goals of AR&RM Responsible for overseeing and where applicable leading cross-functional forward looking project teams relevant to the AR&RM future in addition to the automation ones described above. Support the product categorization list current and communicating internally and externally any changes and their impact. Responsible for contributing to BD&L and M&A projects strategy and assignment of SMEs. Acts as the business liaison with the EVE team until assignment takes place. Representing AR&RM Operations internally to ensure visibility and alignment with stakeholders and functions external to PVSO and PS&PV Supporting AR&RM Office & Strategy Head in recruiting, motivating, developing, and retaining high performing associates to maintain a state-of-the-art organization. Provides regular performance insights of subordinates and supports succession planning as well as their development. Representing Novartis externally; participate and/or join external conferences and networks for respective area of expertise. Deputizing for the Head of AR&RM Office & Strategy in meetings, boards and during holidays. Trains and mentors new AR&RM associates and where required associates from other line functions. Key Performance Indicators 1. Champions creative solutions to simplify processes, automate where possible to increase efficiency and productivity2. Cross functional team feedback on effectiveness of alignment of strategies for capabilities, quality of deliverables, process leanness, cost effectiveness3. Value creation of innovative ideas and their execution.4. Adherence to Novartis policy and guidelines5. Escalation of risks to PS&PV leadership and cross-functional boards adequately managed including effective contribution to boards (MSRB, PMC...)6. Successful outcome of pharmacovigilance audits, Health Authorities inspections and Notified Body certification.7. Recruitment, retention, and development of talent in the internal and external team Minimum Requirements Education and/or professional experience: Graduate/Postgraduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree May be an expert within certain project management methodologies, and/or expertise with multiple methodologies (e.g., Lean Six-Sigma, Agile, …) Languages: Fluent English (oral and written) Experience / Professional Requirements: Demonstrated track record of success leading large scale cross functional/cross-divisional transformative projects or programs encompassing multiple projects. At least 8 years in the industry with direct or indirect leadership experience. Ability to influence and build consensus with senior leaders Excellent planning and tracking skills with attention to detail including experience with project management tools and systems Intermediate knowledge of pharmacovigilance processes, drug development processes, regulatory and business requirements of benefit Enterprise mindset and strategic vision Negotiation and conflict management skills Leads with emotional intelligence Strong interpersonal skills and expert team player with demonstrated ability to build collaborations Strong verbal and expert written communication skills Knowledge of software applications (e.g., MS Project, Microsoft Word, PowerPoint, Excel, Office 365 SharePoint, Teams). Knowledge of Novartis organizational structure and working practices is an advantage. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Description Safety & PV Specialist I (Review of literature cases) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant information. Skilled in extracting and summarizing key safety information from identified literature sources Thorough understanding of creating and validating search strategies for pharmacovigilance purpose. In depth knowledge of major literature databases such as Embase, PubMed etc. Experience in conducting local literature searches and reviews. Understanding of regulatory requirements with respect to global and local literature. Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and tests. Compiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Maintains safety tracking for assigned activities. Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required. Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. Manual recoding of un-recoded product and substance terms arises from ICSRs. Identification and management of duplicate ICSRs. Activities related to SPOR / IDMP. Quality review of ICSRs. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process. Fosters constructive and professional working relationships with all project team members, internal and external. Participates in audits as required/appropriate. Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities. Qualification Requirements Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job. Safety Database systems and knowledge of medical terminology required. Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet. Ability to work independently and in a team environment. Excellent communication and interpersonal skills, both written and spoken. Good organizational skills with proven ability to prioritize and work on multiple tasks and projects. Detail oriented with a high degree of accuracy and ability to meet deadlines. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Job Purpose (State in one sentence the overall objective of the job) The role provides day-to-day case monitoring, assessment and reporting of quality and adverse event complaint records involving Alcon manufactured products and responds to complaint activities required to comply with local and international regulations, guidelines, and applicable directives. This role may be required to work in shifts. Major Accountabilities (Describe the main results of the job to be achieved) Case Processing: Process case files according to Standard Operating Procedures (SOP). Work with affiliate offices to ensure required dataset has been received/requested. Re-assess the data, ensure accurate product selection and assign required event code(s) in the system. Complete initial and follow-up reporting assessments as information is received (initial report, follow-up questionnaires, phone calls, investigation findings). Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries Launch required quality investigation records. Schedule expedited and periodic regulatory reports based on local and international reporting regulations. Perform and receive quality feedback on case management and coding. Adherence to all corporate compliance guidelines & corporate programs. Maintains a working knowledge of the following: Alcon Products for assigned therapeutic areas and corresponding documentation (Product Information, Directions for Use, Manuals, Promotional materials) Eye anatomy Common diseases Ophthalmic evaluation procedures Eye terminology and abbreviations Safety database(s) and reporting tools Process and review Surgical – Intra Ocular Lens (IOL) complaint records in accordance with Alcon Standard Operating Procedures (SOPs) Provide support in reconciliation activities and audit as required. Evaluate and escalate potential safety issues to management. Role Dimensions: Number of associates: None Financial responsibility: None Impact on the organization: Low Key Performance Indicators (Indicate how performance will be measured: indicators, activities…) KPIs will be outlined in detail in the goal sheet, and will largely be around below parameters: Meets internal and external quality standards Review and close files within prescribed timelines Creates high quality regulatory reports for submission on or before assigned due dates Ideal Background (State the minimum and desirable education and experience level) Education Minimum: Graduation in Science Desirable: Graduation in Optometry/ Pharmacy/M. Pharm/B. Pharm /BDS/BAMS/BHMS/ Biomedical Engineering / Registered Nurse Experience requirement: Minimum: Healthcare professional with 1-2 years of experience Desirable: Experience in Device Vigilance / Pharmacovigilance / Regulatory Submissions / Clinical Research / PVPI/ Medical Coding Languages: Minimum: English (written and spoken) Specific Professional Competencies: Indicate any other soft/technical/professional knowledge and skills requirements Excellent listening ability and communication skills Excellent decision quality and negotiation skills Ability to manage multiple tasks, attention to detail, prioritize work and manage time well Knowledge and understanding of national and international medical device regulations and regulatory guidelines Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-marketing safety practice Basic knowledge of MS Office ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

Job Title: Global Regulatory, RWE & Medical (2RM) Quality Operations Manager Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. Our Team Opella Global Quality is a team of highly motivated people to build the state-of the-art quality with an E2E approach across Opella business and ensure best quality and compliance for our patients safety. Within Global Quality, the Global Science Quality Team is the gatekeeper of quality for all regulated activities in Science (Development & Regulatory, Pharmacovigilance, Medical/Clinical and Innovation projects). We lead and manage the implementation of the Quality management systems within Science organisation to ensure activities and data are managed in compliance with the Global Quality standards and applicable regulatory requirements. Main Responsibilities Of The Mission The purpose of the Global Regulatory, RWE & Medical (2RM) Quality Operations Managers is to support the Global Regulatory, RWE and Medical teams and implement & maintain the Quality Systems to ensure that activities ares conducted and data are generated, documented (recorded), and reported in compliance with the GxP requirements. Execute Global Quality Systems Operations for Global Regulatory, RWE & Medical (2RM) regulated activities Event & CAPA : perform QA assessment, check root cause analysis, investigation report review CAPA and approve closure secure timely closure of investigations and CAPAs escalate risk as required to 2RM Lead and to manager Change control : Create Change Control as per 2RM Quality Lead assessment coordinate until Change Control closure secure timely closure Audit & inspection operations run risk tool contribute to Global/Local audit & inspection preparedness monitor and support CAPA closure Vendors quality management: perform qualification (questionnaire, QTA…) and maintain the list of preferred vendors (G2 market excluded) Performance management : report KPI and escalate issues with remediation plan Quality document & training until Regulatory and Medical TSA exit – under the Global QD & Training head guidance – implement QD & Training management in 2RM perform Gap assessment and maintain Quality documentation Map and maintain 2RM QD packages Update and assigned local & global training curricula to global/local internal & external people Support managers in preparing on-boarding plans Manage CMS & LMS access Report QD & training KPI As the Quality Business Partner for the Global Regulatory, RWE and Medical teams: Provides Quality System expertise and support to Global Regulatory, RWE and Medical teams in the execution of Quality Systems Support Connect access management for Global Regulatory, RWE and Medical teams Manage access review Support manager in access management Elevate Quality Culture As a member of the Science Quality Operations team in Hyderabad Collaborate with other Science Quality Operations managers to standardize and continuously improve operational processes Closely interact with Quality System team and BPOs Back up other Quality Operations managers Maintain Quality processes job aids package As a member of Global Science Quality Report relevant information to prevent or revert quality crisis to Quality Lead and direct manager Manages special projects assigned by supervisor as relevant Participate to the Quality meetings as a Science Quality representative Collaborate closely with the Global Regulatory, RWE and Medical leadto ensure timely execution and full compliance in alignment with Quality strategy About You Experience : solid experience in Quality systems (5-10 years) Soft skills: client orientation, outcome obsessed, looking for simplification, assertiveness, networking capability, collaborative & team worker Technical skills: quality systems– Regulatory, RWE and Medical Education: Graduate in Chemistry, Biochemistry, Pharmacy, Engineering (related fields) Languages: English is compulsory (working language) - other languages welcomed Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers

Job Description This role is responsible for providing technical support to the concerned Sales teams across Bihar, Jharkhand, Assam and West Bengal, by conducting technical trainings related to animal health and products to field sales personnel , organizing and participating in the technical seminars to field veterinarians & customers along with Sales team, attending the customer complaints, meeting Veterinary professionals of field and colleges for sharing of technical inputs, coordinating with Veterinary Service Dept. Corporate and Diagnostic laboratory in disease surveillance, customer requirements and field trials Our Veterinary team use their scientific background to provide technical expertise and education to our customers, sales and marketing teams. With a deep knowledge of pharmacology and animal health we engage scientific exchange with external experts and industry leaders ensuring the scientific value of our animal health portfolio is understood. Responsibilities Primary responsibilities include Providing Technical Services to customers in assigned geography (these services include on-site customer visits along with Sales Team & off-side telephonic support as well) and executing a comprehensive Tech service plan for maximizing Organizational goals. Customer Meetings Meet customers in a group to create awareness about relevant scientific practices and advancements with the objective to become a partner of choice among customers. Technical Upgradation of the Sales team in assigned geography Staying ahead of curve for recent technical development in Ruminant Industry and preparing internal competencies to provide customer support. Supervising Local Clinical Trials and Market support studies under the guidance of Sr. Tech Manager. Publication of Clinical Trials & Market Support Study Outcomes in relevant peer-reviewed Scientific Journals Supervise and provide timely and effective technical materials which maximize selling efforts. Collaboration with relevant Technical & Veterinary Education institutes in assigned geographies to further improve our image as Science Driven Organization Any other relevant task which can help in improving business. Rol Technical support to Pharmacovigilance team P.S The Head quarter for this role can be either Patna or Kolkata and this profile requires extensive travelling Qualifications & Skills Degree in Veterinary Sciences 2-3 years of field experience to handle all field situations and provide technical solutions to customer needs. Freshers and Women candidates are also welcome for this opening. Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Preferred Skills Job Posting End Date 06/30/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R301402

You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in defining, developing, and implementing metrics, standards, and tools to efficiently oversee the performance of the Pharmacovigilance and Medical Devices Vigilance system in terms of medical review of safety cases and management of safety signals. Key Responsibilities: - Conduct medical review of ICSRs, including assessment of Literature cases and authoring of enhanced MAC. - Support safety lead in authoring medical assessment letters based on the bi-annual/six-monthly line listing. - Perform literature review of assigned articles and assist in the review of articles for inclusion in PBRER, DSUR, IB, etc. - Provide support to Therapeutic Areas as per business needs, including co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents. - Assist in monitoring the safety profile of products, including activities such as literature review, medical review of individual cases, and medical evaluation of quality defects. - Co-author the PBRER and provide medical inputs to specific sections, including follow-up activities on HA assessment reports. - Contribute to the medical sections of DSUR, IB, labeling documents, Product Guidance Documents, and Expert Statements. - Support signal detection and evaluation activities for assigned products. - Assist in the preparation of Health Authority queries and other safety-related documents. - Act as a Subject Matter Expert for Medical Function processes and provide support during audits and inspections. - Collaborate with other Global Line Functions across Novartis and Third Parties to meet joint accountabilities. - Contribute to PV&PV initiatives and cross-functional projects to optimize medical review processes and quality. - Assist in the development and optimization of training materials and deliver training to Novartis staff and external stakeholders. Minimum Requirements: - Bachelor of Science in Pharmacy, Bachelor of Science in Nursing, PharmD, PhD in relevant field, or Medical Degree (MBBS or MD) required. - Minimum 3 years of experience in the pharmaceutical industry or related field. - Experience in safety document or medical writing, including proficiency in coding with MedDRA and WHO dictionaries. - Strong understanding of clinical trial methodology, ICH GCP, GVP guidelines, and medical terminology. - Attention to detail and quality focus. - Strong organizational and project management skills. - Excellent communication skills and ability to operate effectively in an international environment. - Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process. - Technical understanding of Biomedical/Biostatistics concepts and strong problem-solving skills. - Good presentation skills. - Proficiency in computer skills, including creating spreadsheets, templates, presentations, and working with safety databases/applications. - Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.,

As a Medical Reviewing PV Author, your primary responsibility will be to review and author Clinical Comment (CCC) for case reports involving Suspected Unexpected Serious Adverse Reactions (SUSAR). You will be tasked with editing the Periodic Report Comment within the Patient Safety database, if applicable. Additionally, you will be expected to engage in activities within the Comments field of the GSP Review Workflow step in the Patient Safety database. This includes reviewing and responding to queries/comments from the Case Owner, which are documented in the Comment field of the GSP Review Workflow step. Your role as Lead Medical reviewer will require strong skills in Pharmacovigilance and ICSR. The industry type for this position is IT/Computers - Software, with a functional area focus on the Pharmaceutical sector. This is a full-time, permanent position falling under the Role Category of Life Sciences and Pharma. If you are passionate about ensuring patient safety through rigorous medical review processes and possess the necessary skills in Pharmacovigilance and ICSR, we encourage you to apply for this role. Please note the following details for the job: - Job Code: GO/JC/21470/2025 - Recruiter Name: Sangeetha We look forward to potentially welcoming you to our team as a key member in our Medical Reviewing PV Author role.,

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts, Bachelor of Pharmacy,Master of Pharmacy

Title: Senior Study Data Manager Grade: L2-1 About The Job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Join our Hyderabad Hub, build a career and you can be part of transforming our business while helping to change millions of lives. Ready? Within the Clinical Trial Team (CTT), the Senior Study Data Manager is responsible for leading the end-to-end Clinical Data Management (CDM) activities and study deliverables supporting study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. He/She is accountable for the quality of CDM deliverables and for ensuring accurate and reliable study data, therefore guaranteeing the reliability of the study results. He/She ensures activities are completed according to agreed standards and timelines. He/She provides comprehensive CDM expertise and supports team members by coordinating cross functional data related activities globally to ensure the flawless conduct of a clinical trial. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities Include Accountability for the quality of CDM deliverables (such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports/Visualizations) and for the delivery of accurate and reliable clinical study data. Liaising directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc.) to coordinate all CDM activities for studies, discussing timelines, and providing CDM updates. Proactively anticipating and remediating CDM issues arising during study conduct and monitoring them until resolution. Defining and implementing data cleaning & validation strategy integrating risk-based approaches. Contributing to the protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, and other review activities during the conduct of a study. Leading study activities with internal and external (e.g., Providers) CDM delivery teams (Database Developers, Data Management Programmers, Central Monitors, etc.) and mentoring new Study Data Managers. Coordinating all external data activities: specifications, loading and reconciliation, including data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, and mobile healthcare. About You Experience: Experience on clinical data management of which, must have been in a project management role. Soft Skills:Project management skills and experience. Anticipate delivery risks. Learn and adapt quickly when facing new problems. Good interpersonal, communication, and presentation skills. Technical skills: Experience with CDM and related regulations (incl. ICH E6 and E8). Risk-based mindset focusing on Quality by Design (QbD) and on what really matters. Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations is a plus Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Join an international innovative biopharma company. Participate in the evolution of Clinical Data Management and deployment of innovations. null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Designation – Regional Medical Advisor / Manager Medical Liaison - Therapeutic Area Based About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Roles & Responsibilities Field based scientific experts in assigned therapeutic area that is responsible in the execution of the Medical Affairs Plan(s) for pre-launch and/or newly launched products/indications. Shapes clinical practice through scientific engagements, partnerships and collaborations with traditional (e.g Specialist KEEs for MSLs & Primary Care Physicians for CSLs), and where appropriate non-traditional (e.g. policy and decision makers, PAGs, government, innovative solution providers) experts, as well as, with internal stakeholders to drive enhanced patient outcomes and the safe and effective use of AstraZeneca medicines. Developing and enhancing professional relationships and partnerships with healthcare professionals and other healthcare ecosystem stakeholders according to the Integrated Engagement Plan. Provides scientific, technical, and pharmaco-economic information to HCPs and key stakeholders through one-on-one discussions and medically lead meetings as experts and confidence generation activities. Can be involved and may lead evidence generation activities as part of the implementation of the medical strategy. Acts as catalysts, with a deep understanding of the health system (environment, priorities, clinical pathways, patient journeys) and its challenges, to gather insights and execute according to the medical strategic plans to deliver strategic, scalable & sustainable clinical practice transformations, enhancing access to equitable quality care for patients and enabling the adoption of our innovative medicines. Typical Accountabilities (Please note below are a comprehensive list of accountabilities that may require adjustment for more junior positions.) In assigned therapeutic area and geographical territory, engages in clinical and scientific exchange with medical and scientific experts, including Healthcare Professionals, and where appropriate non-traditional stakeholders (e.g. policy and decision makers, PAGs, government, innovative solution providers) consistent with medical objectives. Scientific Expertise Maintain clinical/scientific expertise in disease state management, AstraZeneca products, emerging therapies, and the competitive landscape. Contribute to the development and provide project leadership/ management of the therapeutic area Field Medical Strategic Plan (FMSP). Act as a subject matter expert/resource for internal and external stakeholders. Work with internal stakeholders in the development and delivery of appropriate training and mentoring needs within therapeutic area. Scientific Exchange Engage in peer-to-peer level dialogue with key customers and deliver appropriate clinical/scientific content through utilising the correct channel mix, which will differentiate AstraZeneca products from those of other companies. Respond to unsolicited customer inquiries and provide focused and balanced clinical / scientific information that supports the safe and appropriate use of AstraZeneca’s products and services. Provide scientific/clinical support and deliver presentations to internal and external stakeholders. Identify and establish relationships with key customers and other scientific thought leaders for engaging them in ongoing scientific dialogue on AstraZeneca products and unsolicited discussions about compounds in development. Organize and facilitate scientific events such as MSL events, Symposiums, Scientific Exchanges, Advisory Boards/Expert Panels, non-promotional standalone events, Meet the Professor sessions, etc., with KEEs and HCPs. Prioritize these events based on their relevance in the patient journey for the related disease. Deliver informative lectures at scientific events tailored to healthcare professionals, aligning with the field medical communication strategy. Collaborate with KEEs on study proposals (ESR or Local Study) and/or publications of interest to AstraZeneca. Customer Insight Effectively identify, gather, analyse, synthesise, report and forward relevant new knowledge about the external scientific/medical environments to internal stakeholders Provide internal stakeholders with actionable items related to medical / product strategy or clinical development based on customer perspectives. Partner with traditional and non-traditional stakeholders to identify gaps in the patient experience journey as insights to be included in the medical / product strategies. Strategic Relationship Develop peer-level relationships with medical and scientific experts, including Healthcare Professionals and collaborate with other internal teams for other key external stakeholders (e.g. policy and decision makers, PAGs, government, innovative solution providers) consistent with Medical objectives. Identify pre-clinical, clinical, and post-marketing study investigators in alignment with Medical Plans. Support data generation activities including participating in reviews of Investigator sponsored studies. Looks to broaden the My MA contact list where appropriate to include non-traditional KEEs from government, payer groups, researchers and clinical advisors who may support practice change initiatives. Establish win-win partnerships with traditional and non-traditional stakeholders to deliver on strategic, scalable and sustainable solutions addressing patient healthcare access gaps within the ecosystem. Other Responsible for leveraging digital and innovation / technology as enablers for scientific exchange and creating patient centric solutions. Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). Exhibits a robust understanding of the Ethical Interactions Policy, along with relevant standards, local laws, and regulations. Moreover, possesses the ability to provide training to others in this domain. Adherence to internal processes and AstraZeneca Global Field Medical Standards and the external regulations including but not limited to clinical trials, promotional activity (e.g. Local Code of Conduct) and pharmacovigilance activities to meet internal SOP and local regulations. Essential Education, Qualifications, Skills, and Experience Scientific and or a master’s degree in a scientific discipline Excellent oral and written communication and interpersonal skills Ability to communicate internally and externally using the different channel mix. Excellent project management skills Excellent presentation skills High level analytical and conceptual thinking Desirable Doctoral degree in a scientific discipline (e.g. M.D., Ph.D., Pharm.D.) Experience in pharmaceutical industry, regulatory environment, clinical or preclinical research, and knowledge of a therapeutic area disease state and treatment. Experience with basic research, drug discovery, drug development and KEE interactions. Key Relationships to reach solutions Internal (to AZ or team) Medical Function (MA, MedEx, RA, PV, MI, NS, Dx, SMM, etc) Commercial Function (Marketing & Sales) Compliance Team External (to AZ) Healthcare professional Healthcare institution stakeholders Healthcare Ecosystem stakeholders (i.e. Research Institutions, PAYGs, Start-ups, Incubators) Service providers Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. You can find alternative messaging to use in the ‘Global Talent Attraction Story messaging’ section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates! So, what’s next? Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours. If you’re curious to know more then please reach out to (contact person) We welcome with your application, no later than (Month) (XX) Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en If you have site, country or departmental social media then feel free to switch any of the above links. Date Posted 29-Jul-2025 Closing Date 30-Aug-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.