📍 Location: Mumbai/Pune/Chennai/Gandhinagar/Indore 🕒 Experience: 1 to 5 Years 🎓 Qualification: MBBS / MD About the Role: Latinum HR is hiring on behalf of a leading global organization for the position of Medical Reviewer . This role offers an excellent opportunity to work in a high-compliance, detail-oriented environment that focuses on patient safety and pharmacovigilance. Key Responsibilities: Conduct comprehensive medical review of clinical, spontaneous, solicited, and literature-based adverse event (AE) and serious adverse event (SAE) cases. Provide medical assessments , including evaluation of labeling and causality, and drafting of the company causality statement. Ensure the medical accuracy and consistency of all case data: seriousness assessment, coding, narrative, drug history, concomitant medications, lab data, and medical history. Maintain in-depth knowledge of disease biology and safety concerns for both marketed drugs and those in development. Ensure compliance with all relevant local and global SOPs and regulatory timelines . Who Should Apply: Medical professionals (MBBS/MD) with 1–5 years of relevant experience in pharmacovigilance, medical reviewing, or drug safety, who are detail-oriented, analytical, and passionate about contributing to global healthcare safety standards. Show more Show less

Job Summary: We are seeking a dynamic and results-oriented Business Development Manager to drive growth in our Pharmacovigilance services sector, with a special focus on integrating Artificial Intelligence (AI) solutions. The ideal candidate will possess strong knowledge of pharmacovigilance processes, regulatory compliance, and AI-driven innovations, coupled with a proven track record in business development and client relationship management within the life sciences industry. Key Responsibilities: 1. Strategic Growth Development: Identify, evaluate, and pursue new business opportunities in the pharmacovigilance domain, including AI-powered solutions. Develop and implement strategies to expand the company’s market presence and client portfolio. 2. Client Engagement: Build and maintain long-term relationships with pharmaceutical companies, biotech firms, and regulatory agencies. Understand client needs and propose tailored PV and AI solutions. 3. AI Integration in PV Services: Promote AI-driven tools and solutions for adverse event reporting, signal detection, and risk management. Stay updated on emerging AI trends and translate them into business opportunities. 4. Cross-functional Collaboration: Work closely with technical teams, including pharmacovigilance, AI, and data science experts, to develop customized service offerings. Collaborate with marketing to craft compelling proposals, presentations, and campaigns. 5. Market Analysis and Competitive Intelligence: Conduct market research to identify trends, competitive landscape, and emerging needs in PV and AI. Leverage insights to refine business strategies and solutions. 6. Revenue Growth and KPI Achievement: Achieve revenue and sales targets through consistent business development efforts. Monitor and report on sales performance and market dynamics. Qualifications: Educational Background: Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field. Advanced degree (MBA, MPH, or MSc) preferred. Experience: 5+ years of experience in business development within pharmacovigilance, life sciences, or healthcare. Hands-on experience with AI tools or services applied to PV is highly desirable. Skills and Competencies: Deep understanding of pharmacovigilance processes, regulations (e.g., FDA, EMA, ICH guidelines), and compliance standards. Familiarity with AI applications such as natural language processing, machine learning, and automation in pharmacovigilance. Excellent communication, negotiation, and presentation skills. Ability to work in a fast-paced, goal-oriented environment. Preferred Certifications: Certification in pharmacovigilance (e.g., Advanced Pharmacovigilance by DIA) or AI-related courses. What We Offer: Competitive salary and performance-based incentives. Opportunity to work with cutting-edge technologies in PV and AI. A collaborative and inclusive work environment. Show more Show less

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! The Medical Safety Lead, Sandoz in close collaboration with Medical Safety Team Lead/the Global Program Safety Lead (GPSL) Biopharma/Head Medical Safety Sandoz provides robust safety evaluation expertise for assigned products in order to improve patients’ lives and impact on overall Sandoz results. As a member of the Medical Safety organization, prioritizes the safety of patients, ensures optimal patient safety for assigned compounds and shares responsibility for the integration, analysis, and evaluation of internal and external safety information through product lifecycle management. Roles and responsibilities. Owns the safety strategy of the assigned products and ensures ongoing evaluation of the overall safety profile, serving as the medical safety representative for Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Annual Product Quality Reports (APQRs) and medical risk assessments (MRAs). Preparation/review of investigator notifications and periodic medical assessments for ethics committees Medical review of single case reports according to business needs (example SUSARs). Review safety documents prepared by External Service Providers. Performs medical assessment of product quality defects with or without adverse events, including the review of line listings whenever required and proposes relevant market action. Monitoring and evaluation of all safety signals both from internal and external sources including literature sources, single cases and/or aggregate data and presents the assessment to the Sandoz Safety Management Team/ Governance Board / other internal/external boards as needed. Prepares safety responses to inquiries from regulatory authorities, health care professionals or legal queries on the benefit-risk balance of assigned products. Supports Country Organization and other stakeholders on safety related questions when global input is required. Depending on assigned products and portfolio, may support the GPSL/Medical Safety Group Lead and the Senior Medical Safety Lead in submission activities as required by providing pharmacovigilance inputs to initial development and updates of core data sheet (CDS) and its related documents. In this context, the Medical Safety Lead may deputize for the Senior Medical Safety Lead for the preparation of safety documents (e.g. summary of clinical safety, clinical overview) for review by GPSL. Lead/Review the authoring of pharmacovigilance cumulative reviews/clinical overviews to support initial submissions and updates of the company core data sheet (cCDS)/ Safety labels. Provides guidance as appropriate to Case processing team for the coding and causality/expectedness assessment of adverse event reports as and when needed. Provides inputs and collaborates on preparation of Safety Profiling Plan (SPP).Provides safety inputs for clinical and regulatory deliverables including but not limited toclinical study protocols (e.g. - PASS, consortia studies etc.), clinical study reports, investigator brochure and safety management plans. Collaborates productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, and other related departments. Provides relevant inputs for Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed depending upon the portfolio and products assigned. What you’ll bring to the role: 10+ years of experience in PSUR, RMS , aggregate Report writing and Signal Management You’ll receive: Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! Join us! #Sandoz Show more Show less

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Master’s in actuarial science 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 and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements. Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available). 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 Master’s in actuarial science Show more Show less

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech/Master’s in actuarial science 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 part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience. The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracy The Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning Candidates who have completed B.Tech or B.E in Computer science in 2024 & 2025 (if all semester s results are available) 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 BE,BTech,Master’s in actuarial science Show more Show less

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Master’s in actuarial science 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 and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements. Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for? Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available). Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning Experience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. 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 Master’s in actuarial science Show more Show less

Summary To plan and lead Category initiatives for a clearly defined sub-category globally OR one category regionally OR all categories in one country OR multiple cross-divisional categories in one country; to develop the sub-category strategy as part of the wider Category Strategy; to lead proactive sourcing projects, specification definition and demand management, as well as manage sub-category-specific supplier performance and innovation activities. About The Role Position Title: Global Category Manager, Clinical R&D Location : Hyd-india Hybrid Job Purpose The Global Category Manager, responsible to manage Clinical functional services Categories in space of Data Management, Statistical Programming, Trial Monitoring, Regulatory, Pharmacovigilance & Medical Writing, plans and leads all strategic Procurement activities within the assigned categories, at a global level and develops proposals for strategic sourcing decisions. The role provides high value procurement solutions to the business and category strategies; supports third party vendor selection, vendor development, technology management and supplier performance measurement activities. The Global Procurement Category Manager ensures best-in-class delivery of external services in support of functions and to realize year-on-year productivity improvements, cost savings, and process improvements working in close collaboration with Business Stakeholders. Your Responsibilities Include But Not Limited To The role is responsible for all Novartis Global spend for assigned Global Clinical Operations functions. These services have FSP long term engagements with goals for value creation and continuous improvement. Specifically, you will be responsible to develop sourcing strategies for clinical study delivery supporting Novartis’ development pipeline. Establish strategic category plans tailored to assigned categories/sub-categories, in congruence with organizational objectives. Lead the sourcing, negotiation and contracting to leverage buying power and recommend appropriate Procurement strategies and tactics to obtain desired results Support/Lead the design and implementation of executive governance around preferred suppliers the objective of which is to ensure performance delivery, continuous improvement, and access to innovation from supplier arrangements to achieve value contribution targets on a global basis Negotiate complex Commercial Terms and Master Services Agreements working collaboratively with Business Stakeholders, Legal, Data Privacy and Supplier Quality Accountable for a proportion of the overall Clinical category savings target and leads proactive category projects, spanning sourcing projects, demand management and process improvement, as well as managing sub-category specific supplier performance and innovation activities to support the delivery of the global procurement targets. Provide financial and business analysis (e.g. Data mining of supplier spend from Procurement and Financial Systems, output analysis and interpretation), supporting global market intelligence in the category area and acting as the focal point for category subject matter expertise to the global business and procurement community. Support in the indirect management of Clinical Sourcing Managers by assisting in their quarterly and year end reviews, provide support in establishing their goals within the category and assist in their development. Essential Requirements Successful project execution by providing all external solutions in time / at the required quality / within budget as verified by the business. Value Delivery – optimized Total Cost of Ownership and cost productivity/savings in compliance with approved Novartis Finance Productivity guideline. Successful and measurable execution on efficiency programs Measurable and continuous process improvement & compliance assurance. Understanding the Procurement KPIs related to market insights, price and demand development as well as procurement's performance. Compliance with all GxP relevant processes Strong project management and/or other leadership experience. Knowledge of Global R&D Clinical CRO market What You’ll Bring To The Role Master’s Degree/other advanced degree in Lifesciences or Pharmaceutical sciences & MBA degree is preferred A minimum of 12 years’ Core experience in strategic negotiations, alliances, and operations in R&D at a pharmaceutical company or a contract research organization. Emphasis on business, experience with clinical processes and activities and associated ESP services, with excellent understanding of study management and overall integration of clinical data system and processes Why 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 You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards 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. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message 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 Show more Show less

Job Title: Associate Director, Statistical Programming Introduction to role The Associate Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies, maintain programming infrastructure, and ensure compliance with SOPs to produce quality and timely deliverables. This role requires extensive experience and proven skills in the use of SAS within a Statistical Programming environment, along with a complete understanding of statistical programming processes, procedures, and roles. The successful candidate will support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures, and creating all files necessary to support an electronic submission in the eCTD format. Additionally, strong people management and supervisory skills are essential to provide direct line management to statistical programmers, identify training needs, and optimize staff utilization. The role also involves managing the day-to-day activities of external partners in delivering program deliverables. Accountabilities Serve as the Lead Programmer and Manager of the statistical programming efforts. Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards. Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications. Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs. Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications. Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit. Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team. Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary. Create and/or review programming plans, and ensure appropriate resource allocation and prioritization. Act as the primary department contact to ensure that department standards are implemented in all studies. Manage adherence to all company policies, SOPs, and other controlled documents; ensure all programming activities adhere to departmental standards. Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support. Essential Skills/Experience 7+ years statistical programming experience in the CRO or Pharmaceutical Industry. 4+ years project management experience in the CRO or Pharmaceutical Industry. Experience with CDISC SDTM and ADaM models and transforming raw data into those standards. Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion. Strong verbal and written communication skills - ability to clearly and effectively present information. An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance. Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures. Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs. Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle. Advanced experience with: Constructing technical programming specifications. Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Creating all files necessary to support an electronic submission in the eCTD format. Desirable Skills/Experience BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area. Competencies: Accountability Collaboration Decision Quality Drive for Results Perseverance Problem Solving Informing Peer Relationships Time Management Building Effective Teams Managing Through Systems At AstraZeneca's Alexion division, we are driven by our passion for making a difference in the lives of patients with rare diseases. Our unique approach combines the agility of a biotech with the resources of a global biopharma leader. We foster an inclusive culture where innovation thrives, empowering our employees to grow both personally and professionally. Join us to be part of a team that is dedicated to transforming lives through groundbreaking science and compassionate care. Ready to make an impact? Apply now! Show more Show less

Position : Mid-Level Salesforce Developer Experience : 4-7 years Number of Positions : 1 Engagement Type : C2C Contract Duration : Minimum 6 months (with potential extension) Work Mode : Hybrid - Pune-based (office visits as required by the client) Start Date : Immediate Project Focus Support and enhance client solutions in the Pharmacovigilance (PV) and Safety domain of the pharmaceutical industry. Key Responsibilities Develop, configure, and customize Salesforce applications to meet business requirements Ensure seamless integration with existing systems and external third-party platforms Create and maintain technical documentation including process flows and design specifications Perform unit testing and support user acceptance testing Collaborate with cross-functional teams including QA, BA, and Project Managers Provide ongoing technical support, issue resolution, and performance tuning Participate in code reviews to maintain development standards and quality Stay up-to-date with Salesforce platform updates and industry best practices. Requirements Proven experience as a Salesforce Developer Exposure to Pharmacovigilance and Safety (PV/Safety) in the pharmaceutical industry Strong understanding of Apex, Visualforce, Lightning Components, and Salesforce APIs Excellent collaboration, problem-solving, and communication skills. Preferred Direct experience working on PV/Safety-related Salesforce implementations. (ref:hirist.tech) Show more Show less

Location - Kerela Our Team Sanofi's Saath 7 is a structured patient support program designed to enhance diabetes management after patients are prescribed Sanofi’s product. The initiative focuses on providing patient education, and defined patient support to improve patient outcomes. Main Responsibilities Program Implementation and Execution: Execute and oversee PP operations in alignment with organizational SOPs, code of conduct, compliance frameworks and country regulations. Develop and drive regional strategies to optimize patient enrollment, adherence, and overall program efficiency. Ensure seamless coordination with third-party service providers to deliver quality patient support. Regularly evaluate program impact and implement necessary improvements. Report to the Sanofi PP Head/PP Manager and they are regionally based. Serve as the primary point of contact for patient support initiatives in the region, ensuring seamless delivery of services to enhance patient experience and outcomes. Manages Dry Blood Spot (DBS) requests within the Diagnostic Support Program including e-consent processes, oversees High Risk Testing projects ensuring compliance with SOPs and local requirements, while continuously improving processes and providing physician support. Patient Interaction And Support Oversee the PP service provider's patient support, ensuring timely and effective support. Guide counselors in delivering disease education, medication adherence information, and lifestyle modifications as permissible. Foster smooth communication between patients, caregivers, and healthcare professionals to enhance patient experience and adherence. Coordinate patient programs across multiple therapy areas, ensuring consistent implementation of support services and adherence to protocols. Stakeholder Management Establish and nurture partnerships with key stakeholders, including HCPs, to enhance program reach and credibility. Work cross-functionally with internal teams (e.g., medical team, PP Head, PPL manager, Regulatory, PV) and PP service provider to ensure regulatory compliance and program alignment with medical and quality standards. Operational Management Supervise aggregate data tracking and ensure comprehensive reporting in line with compliance mandates. Contribute to PP enhancements by identifying gaps and proposing innovative solutions to strengthen patient engagement and support services. Pharmacovigilance & PTC Reporting Monitor and enforce adherence to Pharmacovigilance (PV) and Product Technical Complaint (PTC) reporting protocols. Ensure that all adverse events and quality concerns are reported promptly and managed in compliance with Sanofi's regulatory and safety guidelines. Work closely with PP service provider to uphold quality standards and maintain program integrity. Ensure all Adverse Events (AEs) are reported to the Sanofi Pharmacovigilance Team within 1 working day. Ensure PTC reports are submitted to the Country Quality Team within 1 working day. Work with third-party providers to maintain data accuracy and compliance with SOPs. Compliance Ensure strict adherence to compliance standards governing PP activities under the guidance of PP Head and PPL Manager. Enforce patient engagement protocols that align with SOPs, data privacy guidelines, and regulatory requirements. Train and oversee PP teams to ensure ethical and compliant execution of program activities. Data Privacy Compliance: PP Coordinators must not handle patient data , per the SOP for Data Privacy Compliance. Patient data must be managed by third-party providers, ensuring compliance with DPDPA and Sanofi’s internal privacy policies. No unauthorized data access or sharing by Sanofi employees, maintaining strict compliance with regulatory requirements. About You Experience: Previously experience in patient support, pharmaceutical industry, or healthcare setting Knowledge: Strong understanding of patient support programs, pharmaceutical regulations, and healthcare systems. Communication and presentation skills Coaching Skill Interpersonal relations and skills to manage customer relations. Leadership and Teamwork skills. Soft Skill- Knowledge of Computer applications (MS office) esp. Excel & PowerPoint Ability to work with huge database. Technical skills: Product knowledge/Market Knowledge. Education: Graduate in Science/Pharmacy/Social Work Languages: English 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 Show more Show less

Our Team Sanofi's Saath 7 is a structured patient support program designed to enhance diabetes management after patients are prescribed Sanofi’s product. The initiative focuses on providing patient education, and defined patient support to improve patient outcomes. Main Responsibilities Program Implementation and Execution: Execute and oversee PP operations in alignment with organizational SOPs, code of conduct, compliance frameworks and country regulations. Develop and drive regional strategies to optimize patient enrollment, adherence, and overall program efficiency. Ensure seamless coordination with third-party service providers to deliver quality patient support. Regularly evaluate program impact and implement necessary improvements. Report to the Sanofi PP Head/PP Manager and they are regionally based. Serve as the primary point of contact for patient support initiatives in the region, ensuring seamless delivery of services to enhance patient experience and outcomes. Manages Dry Blood Spot (DBS) requests within the Diagnostic Support Program including e-consent processes, oversees High Risk Testing projects ensuring compliance with SOPs and local requirements, while continuously improving processes and providing physician support. Patient Interaction And Support Oversee the PP service provider's patient support, ensuring timely and effective support. Guide counselors in delivering disease education, medication adherence information, and lifestyle modifications as permissible. Foster smooth communication between patients, caregivers, and healthcare professionals to enhance patient experience and adherence. Coordinate patient programs across multiple therapy areas, ensuring consistent implementation of support services and adherence to protocols. Stakeholder Management Establish and nurture partnerships with key stakeholders, including HCPs, to enhance program reach and credibility. Work cross-functionally with internal teams (e.g., medical team, PP Head, PPL manager, Regulatory, PV) and PP service provider to ensure regulatory compliance and program alignment with medical and quality standards. Operational Management Supervise aggregate data tracking and ensure comprehensive reporting in line with compliance mandates. Contribute to PP enhancements by identifying gaps and proposing innovative solutions to strengthen patient engagement and support services. Pharmacovigilance & PTC Reporting Monitor and enforce adherence to Pharmacovigilance (PV) and Product Technical Complaint (PTC) reporting protocols. Ensure that all adverse events and quality concerns are reported promptly and managed in compliance with Sanofi's regulatory and safety guidelines. Work closely with PP service provider to uphold quality standards and maintain program integrity. Ensure all Adverse Events (AEs) are reported to the Sanofi Pharmacovigilance Team within 1 working day. Ensure PTC reports are submitted to the Country Quality Team within 1 working day. Work with third-party providers to maintain data accuracy and compliance with SOPs. Compliance Ensure strict adherence to compliance standards governing PP activities under the guidance of PP Head and PPL Manager. Enforce patient engagement protocols that align with SOPs, data privacy guidelines, and regulatory requirements. Train and oversee PP teams to ensure ethical and compliant execution of program activities. Data Privacy Compliance: PP Coordinators must not handle patient data, per the SOP for Data Privacy Compliance. Patient data must be managed by third-party providers, ensuring compliance with DPDPA and Sanofi’s internal privacy policies. No unauthorized data access or sharing by Sanofi employees, maintaining strict compliance with regulatory requirements. About You Overall Experience: 3-5+ years of working in pharma industry/healthcare industry is preferred Previous experience in patient support program in pharmaceutical industry, or healthcare setting would be an added advantage Knowledge: Strong understanding of patient support programs, pharmaceutical regulations, and healthcare systems. Communication and presentation skills Coaching Skill Interpersonal relations and skills to manage customer relations. Team handling experience is preferred Soft Skill- Knowledge of Computer applications (MS office) esp. Excel & PowerPoint Ability to work with huge database. Technical skills: Product knowledge/Market Knowledge. Education: Graduate in Science/Pharmacy/Social Work Languages: English 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 Show more Show less

Job Title: Senior Scientist - In Vitro Secondary Pharmacology Career Level: D Introduction to role: Are you ready to make a significant impact in the world of drug discovery and developmentJoin AstraZenecas Clinical Pharmacology Safety Sciences (CPSS) department, where innovation meets collaboration. Our Safety Innovation team is at the forefront of advancing a diverse pipeline across therapeutic areas, delivering safety science from early discovery through clinical development. We are seeking a talented in vitro pharmacologist to join our Secondary Pharmacology team, contributing to the clinical advancement of new medicines. Accountabilities: In this pivotal role, youll leverage your expertise in pharmacology, toxicology, and biology to collaborate with drug safety specialists and project safety pharmacologists. Your insights will shape drug design during the early phases of discovery, ensuring the selection of safer molecules and developing strategies to mitigate safety risks. Youll generate in vitro pharmacological profiling data at contract research organizations (CROs), identify off-target risks, and interpret pharmacological interactions. Your work will translate in vitro activity into pre-clinical and clinical adverse events, providing crucial guidance for project decisions. Essential Skills/Experience: PhD or Masters or equivalent experience in a relevant scientific field with 4+ years of industrial experience. A strong background in pharmacology (e.g., pharmacology, biology, biochemistry, toxicology, physiology) with a proven track record in driving innovative science, preferably in the pharmaceutical or biotechnology industry. Technical experience in in vitro pharmacological or biochemical assay development and screening (e.g., kinase profiling technologies, radioligand binding, enzyme activity, and functional cell-based systems) applied to various biological target classes. Excellent problem-solving and organisational skills, delivery focus, and outstanding communication skills. A true collaborator with highly effective networking skills and experience collaborating across scientific disciplines, cultures, and expertise. Desirable Skills/Experience: Experience with off-target profiling data and strategies in the pharmaceutical industry. Practical understanding of kinase profiling technologies. Experience working with CRO s, commissioning requests and driving delivery processes. Experience with being entrepreneurial taking the initiative in projects. Demonstrated leadership in scientific projects or teams. Experience in regulatory interactions or safety assessments. Knowledge of emerging trends in drug safety and pharmacovigilance. At AstraZeneca, we are driven by curiosity and courage, exploring what science can achieve. Our commitment to making a difference is unwavering as we fuse data and technology with scientific innovation to tackle some of the worlds most complex diseases. We celebrate successes and learn from failures, creating an inclusive environment where diverse knowledge is leveraged for swift impact on disease. With opportunities for lifelong learning and career growth, AstraZeneca is where you can push boundaries and deliver life-changing medicines. Ready to make a differenceApply now and be part of a team that transforms patient lives through groundbreaking science! Date Posted 23-May-2025 Closing Date 03-Jun-2025

Summary The primary responsibility of this role is to manage patient oriented program (POP). Responsible to ensure compliance in POP end to end activities as per the applicable process and quality standards. Liaison with the cross functional team for successful execution of POP. About the Role Analyst Patient-Oriented Program Location - Hyderabad #LI Hybrid About the Role: The primary responsibility of this role is to manage patient oriented program (POP). Responsible to ensure compliance in POP end to end activities as per the applicable process and quality standards. Liaison with the cross functional team for successful execution of POP. Key Responsibilities: Administer end to end POP process on behalf of Business Owner (BO) in accordance with Doing Business Ethically (DBE) policy and POP Standard Operating Procedures (SOP). Coordinate with all POP stakeholders (POP Champion/ Procurement/ Legal/ Patient Safety/ Compliance/Quality Assurance) and create POP documents. Responsible for obtaining the necessary approvals for conduct of POP in a timely manner. Responsible for the overall management of the External Service Providers (ESP) compliance check prior to fieldwork initiation. Enter program details in the POPsys database throughout the conduct of the POP. Keep track of all required activities (First Participant First Contact (FPFC)/Last Participant Last Contact (LPLC) dates, Adverse Event Reconciliation (AER), Periodic Reviews, closure, etc.) related to POP conduct and ensure no monitoring gaps before program closure in POPsys. Maintain documentation for all POP related activities in POP repository. Ensure identified quality issues are well documented in quality issue (QI) management tool. Create issue record and perform proper investigation, root cause analysis followed by risk assessment and corrective and preventive actions (CAPA). Ensure proper handover of activities when leaving the role/organization/planned leaves and liaise with POP Champion. Effective management of all projects assigned, and timely escalation of findings related to projects. Seek constant feedback from stakeholders and improve on suggestions put forth. Essential Requirements: Preferrable experience with 2- 5 years experience in the pharmaceutical industry within Clinical, Pharmacovigilance (PV), Medical/regulatory Affairs, or relevant experience in pharma compliance or commercial framework. Good understanding of local regulatory requirements and applicable policies surrounding pharmaceutical industry Ability to communicate effectively across different audiences, organizational levels and local and global teams. Desirable Requirements: College/university degree, preferably in security, criminal justice, crisis management, business continuity or other related field. Advanced degree is highly desirable (e.g., Master s degree or MBA). Why 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 thisWith 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

Job Description Job Overview Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate

Regional Medical Advisor (RMA) - General Specialty Medicine, North Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities and Primary Activities Scientific Expertise : Develop and maintain a comprehensive understanding of the companys products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement : Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the companys products and therapeutic areas. Support to Medical Strategy : Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education : Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange : Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication : Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support : Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration : Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives : Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information : Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training : Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance : Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the companys strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background : A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience : At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise : Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge : Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills : Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills : Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility : Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge : Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Required Skills: Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} 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.

We are looking for a Life Science Senior Content Specialist to join our team in Hyderabad/Noida . This is an amazing opportunity to work on OFF-X, a translational drug safety intelligence portal . The team consists of 20 people located in Spain and India and is reporting to the India-based Team Manager. We have a great skill set in the analysis of drug safety and toxicity data and we would love to speak with you if you have skills in that area About You - experience, education, skills, and accomplishments Degree in Life Sciences (Pharmacy, Pharmacology, Toxicology, Biology, Biomedical Sciences, etc.) Min 5 years of experience in drug safety, toxicology, pharmacovigilance Excellent English written and oral communication skills Attention to detail, results orientated, enthusiastic, determined to achieve and shows commitment It would be great if you also had . . . Ability to analyze large volumes of structured or unstructured data. Ability to delve deep into content and results. Interpersonal skills and the ability to work independently and collaboratively with a team Self-starter with the ability to multitask and prioritize across projects to meet deadlines Good skills of problem-solving and good judgment in decision-making and setting priorities. What will you be doing in this role Selection of appropriate scientific articles and conference content for the project. Analysis and interpretation of published data (clinical trials, journal articles, reviews, meta-analysis, congress communications, drug approval reports, etc.) Collection and curation of information on risks and safety of drug products (recording, archiving, updating and evaluating the information) Writing case studies, reports and reviews Maintain informed discussions with experts and customers About the Team Our editorial team is a group of 20 people creating and delivering content for OFF-X, a translational drug safety intelligence portal that allows user to easily identify new safety liabilities. We are a global team based on India and Spain with more than 50 years of experience in the sector. We create and classify content for more than 300 references every week, including Journals, Congress publications and Regulatory documents. In this team you will have the opportunity to be up-to-date with all the new advances in the drug development industry and you will be constantly learning new things. Location - Hyderabad / Noida

We are looking for a Life Science Senior Content Specialist to join our team in Hyderabad/Noida. This is an amazing opportunity to work on OFF-X, a translational drug safety intelligence portal. The team consists of 20 people located in Spain and India and is reporting to the India-based Team Manager. We have a great skill set in the analysis of drug safety and toxicity data and we would love to speak with you if you have skills in that area About You – Experience, Education, Skills, And Accomplishments Degree in Life Sciences (Pharmacy, Pharmacology, Toxicology, Biology, Biomedical Sciences, etc.) Min 5 years of experience in drug safety, toxicology, pharmacovigilance Excellent English written and oral communication skills Attention to detail, results orientated, enthusiastic, determined to achieve and shows commitment It would be great if you also had . . . Ability to analyze large volumes of structured or unstructured data. Ability to delve deep into content and results. Interpersonal skills and the ability to work independently and collaboratively with a team Self-starter with the ability to multitask and prioritize across projects to meet deadlines Good skills of problem-solving and good judgment in decision-making and setting priorities. What will you be doing in this role? Selection of appropriate scientific articles and conference content for the project. Analysis and interpretation of published data (clinical trials, journal articles, reviews, meta-analysis, congress communications, drug approval reports, etc.) Collection and curation of information on risks and safety of drug products (recording, archiving, updating and evaluating the information) Writing case studies, reports and reviews Maintain informed discussions with experts and customers About The Team Our editorial team is a group of 20 people creating and delivering content for OFF-X, a translational drug safety intelligence portal that allows user to easily identify new safety liabilities. We are a global team based on India and Spain with more than 50 years of experience in the sector. We create and classify content for more than 300 references every week, including Journals, Congress publications and Regulatory documents. In this team you will have the opportunity to be up-to-date with all the new advances in the drug development industry and you will be constantly learning new things. Location - Hyderabad / Noida At Clarivate, we are committed to providing equal employment opportunities for all qualified persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations. Show more Show less

Fresher Hiring 2023 - 2025 Passouts only - All India Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Role & responsibilities Perform data reconciliation between different data sources and study documents to ensure data integrity and consistency across datasets. Generate data queries to address discrepancies, inconsistencies, and missing data identified during data review, ensuring timely resolution and documentation of data queries Communicate data queries to investigative sites, data managers, and study personnel, following up on query responses and resolving discrepancies in collaboration with relevant stakeholders Identify deviations from protocol-specified procedures, eligibility criteria, and data collection guidelines, escalating issues to appropriate personnel for resolution Perform quality checks and data validation procedures to ensure accuracy, consistency, and reliability of clinical trial data, adhering to data management standards and industry best practices Assist in the development and implementation of data validation plans, data review guidelines, and quality control procedures to maintain high standards of data quality and integrity. Assist in a variety of specialties including but not limited to primary care, orthopedics, rheumatology, etc. Updates patient history, physical exam, and other pertinent health information in the document as required. Complies with Compliance standards of the Organization as laid by HIPAA. Performs other duties and tasks to improve provider productivity and workflow as assigned by supervisors. Assist documenting the patients, electronic health record (EHR). Fresher Hiring - Pharma / Life Sciences / Medical Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Location - All India - Delhi, Mumbai, Pune, Bangalore, Kochi, Chennai, Hyderabad, Ahmedabad, Bhopal, Indore, Kolkata, Chandigarh

Summary LOCATION: Barcelona, Spain or Hyderabad India This role is responsible for managing the external vendor and partner engagements, as well as product and program management and communication efforts for the Technology & Systems team of the Patient Safety and Pharmacovigilance (PS&PV) function. This role ensures the successful execution of programs and operations of technology products in line with strategic and operational goals and maintains effective collaboration with external partners as well as with internal stakeholders. About The Role Key Responsibilities: Develop and maintain strong relationships with key strategic partners and vendors for Technology delivery for PS&PV. Advise function leadership on best practices for supplier engagement and strategy. Leverage partner capabilities to deliver differentiated PS&PV technology products and services based on knowledge of internal system architecture needs and strategic evolution, as well as external trends and best practices Actively oversee the engagement of key service providers in collaboration with the Procurement function, monitor vendor performance, and ensure adherence to contractual agreements. Provide leadership and guidance for key strategic programs in PS&PV by applying best practices in project and program management. Identify and mitigate risks and issues in program and project execution, as well as day-to-day operations. Lead the application of enterprise-level Program Management Governance framework and best practices within PS&PV programs. Serve as the change management and communication lead for the Technology & Systems team within PS&PV. Deliver timely updates on project and operational milestones, achievements, issues, and risks to relevant stakeholders. Oversee training curricula and capability-building initiatives for the Technology & Systems team based on a thorough understanding of organizational strategy and priorities. Essential Requirements Minimum of 5 years of experience in a Senior Technology or Business role within the Life Sciences industry. Experience in technology vendor management in a multi-national corporation. Proven ability to manage complex projects and programs. Strong relationship-building skills with partners and vendors. Strong communication and presentation skills. Ability to manage multiple priorities and work effectively in a fast-paced environment. Experience in change management and driving organizational improvement initiatives, including organizational capability building. Preferred: Knowledge of business processes in Patient Safety and Clinical Development and thorough understanding of GxP requirements. Key Performance Indicators Strength and effectiveness of vendor relationships. Successful execution and delivery of PS&PV projects and programs within scope, time, and budget. Effective risk and issue management in project execution. Quality and timeliness of communication with stakeholders. Capability advancement for Technology & Systems team Languages Fluent in spoken and written English 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 Show more Show less

Job title : Senior Medical Regulatory Writer Hiring Manager: Head Scientific Communications/ Team lead Location: Hyderabad % of travel expected: Travel required as per business need Job type: Permanent and Full time About The Job Our Team: Sanofi Business Operations 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 Business Operations 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 Soft skills: Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment 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) Education: Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Languages: Excellent knowledge of the English language (to read, write, and speak) 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 Show more Show less

Job description: Job Description Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs ͏ Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLA’s defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements ͏ Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers’ and clients’ business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs ͏ Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks ͏ Deliver No Performance Parameter Measure 1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completed Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma) . Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome. Show more Show less

Job Overview The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product’s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req Two (2) years of pharma experience Pref Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less

This role is responsible for managing the external vendor and partner engagements, as we'll as product and program management and communication efforts for the Technology Systems team of the Patient Safety and Pharmacovigilance (PSPV) function. This role ensures the successful execution of programs and operations of technology products in line with strategic and operational goals and maintains effective collaboration with external partners as we'll as with internal stakeholders. About the Role Major accountabilities: Develop and maintain strong relationships with key strategic partners and vendors for Technology delivery for PSPV. Advise function leadership on best practices for supplier engagement and strategy. Leverage partner capabilities to deliver differentiated PSPV technology products and services based on knowledge of internal system architecture needs and strategic evolution, as we'll as external trends and best practices Actively oversee the engagement of key service providers in collaboration with the Procurement function, monitor vendor performance, and ensure adherence to contractual agreements. Provide leadership and guidance for key strategic programs in PSPV by applying best practices in project and program management. Identify and mitigate risks and issues in program and project execution, as we'll as day-to-day operations. Lead the application of enterprise-level Program Management Governance framework and best practices within PSPV programs. Serve as the change management and communication lead for the Technology Systems team within PSPV. Deliver timely updates on project and operational milestones, achievements, issues, and risks to relevant stakeholders. Oversee training curricula and capability-building initiatives for the Technology Systems team based on a thorough understanding of organizational strategy and priorities. Key performance indicators: Strength and effectiveness of vendor relationships. Successful execution and delivery of PSPV projects and programs within scope, time, and budget. Effective risk and issue management in project execution. Quality and timeliness of communication with stakeholders. Capability advancement for Technology Systems team Minimum Requirements: Work Experience: Minimum of 5 years of experience in a Senior Technology or Business role within the Life Sciences industry. Experience in technology vendor management in a multi-national corporation. Proven ability to manage complex projects and programs. Strong relationship-building skills with partners and vendors. Strong communication and presentation skills. Ability to manage multiple priorities and work effectively in a fast-paced environment. Experience in change management and driving organizational improvement initiatives, including organizational capability building. Preferred: Knowledge of business processes in Patient Safety and Clinical Development and thorough understanding of GxP requirements. Languages : Fluent in spoken and written English

Summary In line with overall product strategy, the Medical Advisor is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders About the Role Key Responsibilities Support country medical affairs strategy in line with the global strategy, country insights and market conditions, and implementation of Medical Affairs activities within the designated therapy area(s). Coordinate scientific meeting, symposia, congresses, Continuous Medical Education (CME) and other medical / scientific exchange and engagement activities which could bring value to the therapy area; develop engagement plan(s) for country customer-facing activities and events, and ensure timely execution of the activities in an efficient and compliant way. Ensure enquiries are responded to in a quality, timely manner, and in accordance with applicable standards; establish response documents for frequently asked questions. Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies / clinical research within the therapeutic area. Support country strategy for Non Interventional Studies/Investigator Initiated Trial activities. Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for partner engagement and events are tailored to local needs, and reviewe'd/approved per local/P3 guidelines. Ensure medical insights are provided to cross-functional groups, including, but not restricted to: Pharmacovigilance, Regulatory Affairs, Market Access, QA, Commercial and Brand team and others. Responsible for risk identification and assessment, mitigation planning as we'll as implementation and monitoring of appropriate internal controls within the area of responsibilities Essential Requirements: MBBS; MD Mandatory with min 1+ year industry experience Operations Management and Execution Project Management Collaborating across boundaries Clinical Trial Design, Data Reporting Medical Science and Disease Area Knowledge Medical Education and Scientific Engagement Non-Interventional Studies (NIS) / Epidemiology Studies Medical Governance and Medical Safety Desirable Requirements: Cardiovascular

Aster Pharmacy (India) is looking for Resident.Anaesthesiology.MIMS Hospital Calicut to join our dynamic team and embark on a rewarding career journey Administer anesthesia for surgeries and procedures Monitor patient response and vital signs Collaborate with surgical teams for safety Manage post-operative recovery and pain control