1158 Pharmacovigilance Jobs - Page 2

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient 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? Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Understanding of Pharmacovigialnce Experience in Medical Review of ICSRs Medical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals - Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP - Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables - Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable - Performs labelling of events of applicable cases - Provides Medical Expertise to case processing team whenever required - Provides training/mentoring to the team members wherever applicable MBBS,MD Show more Show less

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. You will be expected to coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? Commitment to quality Agility for quick learning Adaptable and flexible Ability to work well in a team Ability to meet deadlines Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Bachelor of Pharmacy Show more Show less

Description Medical Writer I Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision. Develops or supports, a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinicalstudy reports; o Patient narratives; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills. Is aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications 1. Any Life Science postgraduate-Prefer M.Pharm,PharmD 2. Candidates having experience in Clinical Trial Disclosure, Regulatory Medical Writing, Pharmacovigilance (Safety Narrative Writing). 3. Responsibilities include drafting CTD documents for clients and performing quality checks (QC) documents 4. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EUCTR 0. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

PLEASE NOTE - THIS IS A HEALTHCARE MARKET RESEARCH ROLE (NOT AN IT OR A SOFTWARE DEVELOPMENT ROLE) Konovo is a global healthcare intelligence company on a mission to transform research through technology- enabling faster, better, connected insights. Konovo provides healthcare organisations with access to over —the largest network of its kind globally. With a workforce of over 200 employees across 5 countries: India, Bosnia and Herzegovina, the United Kingdom, Mexico, , we collaborate to support some of the most prominent names in healthcare. Our customers include over 300 global pharmaceutical companies, medical device manufacturers, research agencies, and consultancy firms. As we transition from a service-oriented model to a product-driven platform, we are expanding our hybrid Bengaluru based team. We are looking for a Data Quality Analyst, Compliance to contribute to our mission by by ensuring the highest standards of data quality and compliance for global research studies, monitoring patient safety events, conducting thorough data reviews, and collaborating with Client Services and Compliance teams to meet client requirements. Your role will directly impact patient safety and data accuracy, supporting the timely reporting of safety events and the organisation's training programs. How You'll Make an Impact: Partner closely with the Client Services team to proactively monitor both domestic and global research studies, ensuring data integrity and adherence to quality standards. Collaborate with the Compliance team to swiftly identify and escalate adverse events, product complaints, and other special situations involving client products, particularly those impacting patient safety. Ensure accurate and timely submission of patient safety events and reconciliation reports, in strict alignment with client pharmacovigilance requirements and regulatory expectations. Act as a Quality Analyst, specializing in patient safety and data quality oversight across a high volume of survey data. Conduct thorough daily reviews to validate data accuracy, enforce compliance protocols, and deliver actionable insights to the Client Services and Compliance teams. Maintain accountability for timely and accurate reporting of safety-related findings to client pharmacovigilance departments. Contribute to the success of the organization's Patient Safety Reporting Training Program by supporting its execution and ongoing development. Execute responsibilities that consistently require sound judgment, independent decision-making, and a high level of discretion in a fast-paced, data-driven environment. What We're Looking For: 1+ years of experience in Data Quality Control, preferably within the Healthcare Market Research industry Demonstrated commitment to excellence, with the ability to adapt quickly to evolving needs. Exceptional analytical capabilities, coupled with outstanding written and verbal communication skills, including strong comprehension and articulation. Fluent (speaking, reading, writing) in English Strong communication skills, both written and verbal, and the ability to work in cross-functional teams. Proven ability to multitask, prioritize effectively, and navigate ambiguity with confidence. Meticulous attention to detail, with strong record-keeping and document management skills. Highly self-motivated and capable of working independently with minimal supervision. Willingness to maintain a flexible schedule to meet project timelines, including coverage during U.S. Eastern Time Zone hours (9:00 AM to 5:00 PM EST) and occasional weekend shifts as part of a rotating schedule. High attention to detail and proven ability to work in a fast-paced environment. Proficiency in Microsoft Office Suite Why Join Konovo? Be part of a mission-driven organisation that is empowering life science researchers and data scientists with the broadest ecosystem of healthcare audiences and an intelligent, AI-enabled platform — so insights aren't just collected, they're connected. Join a fast-growing global team with opportunities for professional growth and advancement. Enjoy a collaborative and hybrid work environment that fosters innovation and flexibility. Experience a workplace that puts employees first, offering a workplace designed for growth, well-being, and balance. Become a part of an organisation that prioritizes your well-being with comprehensive benefits, including group medical coverage, accident insurance, and a robust leave policy. Our employee-centric policies ensure a rewarding and fulfilling work experience. Make a real-world impact by helping healthcare organisations innovate faster. This is just the beginning of what we can accomplish together. Join us at Konovo and help shape the future of healthcare technology! Apply now to be part of our journey. Show more Show less

About the Company Qinecsa is a trusted, global partners bringing together best-in-class technology and scientific expertise to connect life science companies, public health, and regulatory sectors to the right safety solutions. we take pride in being the leading specialist pharmacovigilance provider, offering unparalleled expertise in PV services, technology, and consulting to cater to the unique needs of small, medium, and large pharmaceutical companies Location: India Job Type: Full-Time Job Description: We are seeking a Consulting Technology Project Manager to manage client implementation projects for our Pharmacovigilance SaaS solutions. The ideal candidate will be a dynamic client facing services professional with extensive project management experience in the life science technology domain. This is a strategic role requiring deep project management expertise, pharmaceutical domain knowledge, and excellent leadership skills. Key Responsibilities: Lead end-to-end project management of client software implementations, upgrades, and integrations. Develop and manage project plans, including timelines, budgets, and resource demand, and author project initiation documents. Coordinate cross-functional, global teams to ensure successful project delivery. Serve as the primary point of contact for senior client stakeholders, ensuring clear communication and strong relationship management. Ensure the accuracy, reliability, and performance of all project deliverables. Monitor project progress and performance, identifying and mitigating risks and issues as they arise. Facilitate regular project status meetings and provide updates to stakeholders. Actively manage project scope and costs, ensuring any changes are documented and approved through formal change control processes. Develop and maintain comprehensive project documentation, including project initiation documents, risk management plans, and post-project reviews. Ensure all projects comply with industry regulations, particularly those related to pharmacovigilance and data privacy (e.g. GxP, GDPR). Coordinate and manage interactions with third-party vendors, consultants, and partners to ensure successful delivery and integration of external components or services. Support continuous improvement of project management processes, tools, and best practices within the organization. Mentor and guide junior project managers and team members, fostering a collaborative and high-performance team environment. Characteristics: Well-organized self-starter with attention to detail. Excellent client facing communication and problem-solving skills. Strong written, communication, and interpersonal skills. A desire to learn about our proprietary products Essential Experience and Qualifications: Bachelor's or Master's degree in Computer Science, Information Technology, Project Management, or a related field. 8+ years of experience in project management, with at least 5 years in a senior or lead role delivering software solutions to pharmaceutical or life sciences clients. Proven experience managing pharmacovigilance, clinical, or regulatory technology projects. Knowledge of pharmacovigilance workflows and regulatory standards (e.g., ICH E2E, GVP Modules, FDA, EMA). Expertise in project management methodologies (e.g., Agile, Scrum, Waterfall). Proficiency in project management tools (e.g., Microsoft Project, Jira, SmartSheet). Preferred Experience and Qualifications: Familiarity with signal detection, case management, and safety databases (e.g., Argus, ARISg). Familiarity with cloud-based solutions and big data technologies. Technical background with experience in software development or IT infrastructure. Knowledge of regulatory requirements and industry standards for technology solutions. Certification in project management (e.g., PMP, PRINCE2). What We Offer: Competitive salary Opportunity to work with a dynamic and innovative team and world-class clients. Professional development and growth opportunities. A collaborative and inclusive work environment. Work from home with limited travel. How to Apply: Interested candidates are invited to submit their resume and cover letter to roopa.shree@qinecsa.com Show more Show less

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission. Job Title - Medical Reviewer Location: Gurgaon Summary: The Medical Reviewer (MR) is responsible for: Provide medical review for individual case safety reports, including: coding, seriousness, expectedness, Baxter causality assessment. Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment. Potential review of periodic documents, and product labels. Essential Duties and Responsibilities: Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment. Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities. Support the Safety Operations team, providing expertise for the case processing team for medical questions e.g., coding of events, understanding coding conventions, splitting of cases etc. Maintain knowledge of global regulatory authority regulations (especially FDA and EMA). Contribute to the training, leadership and continuing education for all departmental staff. May perform benefit-risk safety analysis, including: safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans and REMS, Regulatory Authority assessment reports and queries, and periodic documents, such as PSURs, PBRERs, and PADERs. Qualifications: Knowledge of industry regulations and drug safety practices globally. Knowledge of adverse event case report triage processing. Experience with commercial databases and safety coding dictionaries (MedDRA, WHOART, COSTART, etc.). Excellent oral and written communication skills. Excellent teamwork and interpersonal skills are required. Strong skills in presenting drug safety topics for regulatory authorities or at conventions, meetings, etc. Education and/or Experience: A medical degree (or equivalent) and board certification/eligibility are required. Two years of experience post-residency, with at least one year of experience in pharmaceutical/biotechnology company. Exposure to working relationship with FDA, EMA, or other regulatory authorities is preferred. Knowledge and understanding of national and international regulatory guidelines are a plus. Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice. At Baxter, we offer a dynamic and future focused work environment offering workplace flexibility, additional annual leave and a strong value driven culture. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. EEO (Equal Employment Opportunity) Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

The SMW will be responsible for authoring the signal management reports including Validations, SERs, HA requests etc. The scientist will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc. Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO. Conduct/support signal detection and evaluation activities according to SOPs and guidelines Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting Maintaining a good working knowledge of the assigned Clinical studies for narratives Attending/conducting internal, drug safety and project specific training sessions Imparting trainings to the new starts during the induction sessions and the team as required. Skills: Analytical and problem-solving skills Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently A flexible attitude with respect to work assignments and new learning Ability to negotiate on behalf of the department to ensure resources, timelines and expectations are aligned Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Fluency in written and spoken English Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point) Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Provides departmental expertise and perspectives to promote prospective business opportunities. Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text Typing and transcription accuracy Knowledge and Experience : Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field. Good knowledge of medical terminologies Education: Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.) A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage #LI-REMOTE

Job Purpose: Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Signal detection/analysis/evaluation and ongoing safety surveillance activities Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Case report Medical review Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to case processing team Skills: Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge and Experience : Good knowledge of medical terminology. Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred. Education: MBBS/MD #LI-REMOTE

Summary In this role you will lead an impactful deliverable across the pharma value chain from drug discovery to commercialization by leveraging Indepth understanding in business process and Generative AI About The Role Major accountabilities: Domain Expertise: Possess a knowledge across the end-to-end pharmaceutical value chain, including drug discovery, preclinical and clinical trials, regulatory affairs, pharmacovigilance, technical operations (manufacturing, supply chain, and quality assurance), and commercial operations (market access, sales, and marketing), to lead AI-driven initiatives. Stay updated on advancements in Generative AI and their applications to optimize processes across the pharmaceutical value chain, from R&D to commercialization. Business Analysis: Partner with senior stakeholders across R&D, manufacturing, and commercial teams to gather, document, and analyse complex business requirements, ensuring alignment with strategic organizational goals. Conduct in-depth analyses of business processes across the E2E value chain, identifying opportunities for Generative AI to enhance efficiency, quality, and market competitiveness. Develop detailed business cases, feasibility studies, and cost-benefit analyses to prioritize AI initiatives in drug development, manufacturing optimization, and commercial strategies. Create comprehensive business requirements documents, process flow diagrams, and solution blueprints to guide AI implementation across the value chain. Stakeholder Engagement: Translate complex AI concepts into actionable insights for technical and non-technical stakeholders in R&D, technical operations, and commercial teams, securing buy-in and alignment. Facilitate workshops, strategy sessions, and cross-functional meetings to drive consensus on AI projects spanning discovery to commercialization. Mentor junior analysts to build team capability in AI-driven business analysis within the pharmaceutical value chain. Generative AI: Leverage Generative AI to analyse large, complex datasets across the value chain, uncovering patterns, trends, and insights for applications like drug candidate identification, manufacturing process optimization, and market demand forecasting. Collaborate with data scientists and AI engineers to design, develop, and deploy AI models tailored to specific needs in R&D, manufacturing, and commercial operations. Ensure AI solutions are interpretable, scalable, and integrated into workflows across the E2E value chain, from lab to market. Regulatory & Ethical Compliance: Ensure AI solutions comply with global regulatory requirements (e.g., USFDA, EU, PMDA) and ethical standards across all stages of the pharmaceutical value chain, including manufacturing and commercial activities. Identify and mitigate risks related to AI deployment, such as data privacy, model bias, and compliance with Good Manufacturing Practices (GMP). Minimum Requirements Possess 6–8 years of core Business Analyst experience in the life sciences domain, with at least 3 years focused on AI technologies across the pharmaceutical value chain (R&D, manufacturing, and commercial operations), complemented by a master’s degree in Life Sciences, Biomedical Sciences, Computer Science, Data Science, or a related field. A PhD is a plus. Strong understanding of Generative AI, machine learning, and their applications in drug discovery, clinical trials, manufacturing, and commercial strategies. Proficiency in data analysis and visualization tools (e.g., Python, R, Tableau) to interpret complex datasets. Proven project management skills, with a track record of leading AI-related projects in at least one segment of the pharmaceutical value chain. Strong analytical and problem-solving abilities, with a strategic mindset and attention to detail. Exceptional communication and interpersonal skills, with the ability to mentor teams and influence stakeholders across R&D, technical operations, and commercial functions. Familiarity with pharmaceutical regulatory requirements (e.g., FDA, EMA, PMDA) and industry standards, including GMP and commercial compliance. Why consider Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn More Here https://www.novartis.com/about/strategy/people-and-culture Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

Summary Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety support to the clinical development teams. About The Role Major accountabilities: Monitors the clinical safety of projects /products including activities such as literature review, evaluation of individual cases or signal detection, and responds to safety related questions appropriately . Performs medical assessment and related activities for cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, review of line listings of single cases, and preparation of investigator notifications and periodic medical assessments for ethics committees. Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal detection, monitoring and evaluation of all safety signals. Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for Health Authority review boards. Provides inputs to responses for legal queries and Country Organization requests involving safety issues. Provides expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products. Collaborates productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments. Contributes to the development of departmental goals and objectives. Distribution of marketing samples (where applicable) Key Performance Indicators Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations and procedures -Compliance, consistency and quality of safety deliverables Minimum Requirements Work Experience: People Challenges. Critical Negotiations. People Leadership. Collaborating across boundaries. Operations Management and Execution. Skills Clinical Trials. Functional Teams. Literature Review. Management Skills. Medical Information. Medical Records. Medical Strategy. Pharmacovigilance. Regulatory Compliance. Risk Management. Safety Science. Languages 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

Work Schedule Second Shift (Afternoons) Environmental Conditions Office Job Description Purpose: Subject matter expert of day-to-day application configuration and maintenance activities of the Pharmacovigilance (PV) Safety database Oracle Argus, ensuring that performed tasks comply with SOPs and policies, industry standards, and applicable regulations. Provides technical solutions, support systems implementation and testing following change control procedures and provide systems administration to support the requirements and initiatives of the PV Safety group. Responsibilities include but are not limited to: Collaborates with PV business users to understand the requirements and recommend solutions. Creates custom and ad-hoc reports from the PV Safety database using built in tools, OBIEE, or SQL. Develops and validates aggregate safety reports. Assists with internal and external audits of the PV Safety database. Interacts with project team or client and seeks feedback on deliverables. Provides programming support to project teams and clients for safety data review, ad-hoc reports and other activities. Leads project initiatives as needed, ensures desired outcome is achieved on time and in scope. Reviews and makes recommendations for process development and improvement. Manages assignment to meet timelines and deliver high quality work. Estimates effort to assist in bidding activities or cost construction. Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) Knowledge, Skills and Abilities: System administration experience in Oracle Argus including current knowledge of safety system configuration, database structure, mappings requirements and transformation rules Strong experience generating reports Strong SQL programming skills Knowledge of relational data base structure and experience working with complex data systems Proficient of one or more programming languages Strong attention to detail Problem solving skills Good written and verbal communications skills Ability to independently and effectively organize and manage multiple assignments with challenging timelines Ability to adapt and adjust to changing priorities Demonstrated leadership, initiative and motivation Ability to mentor and direct the work of junior staff Ability to communicates effectively within a multi-disciplinary team Ability to complete assigned tasks on time and within budget

Summary In this role, he will drive a strategic AI transformation across the pharmaceutical value chain, from drug discovery to commercialization, by leading enterprise-wide initiatives and coaching sub-ordinates to deliver high-impact solutions. About The Role Major Accountabilities Domain Expertise: Serve as a strategic expert in life sciences, providing leadership in applying Generative AI to drug discovery, clinical trials, regulatory affairs, pharmacovigilance, and market access. Drive thought leadership by identifying and promoting innovative Generative AI applications to position the organization as an industry leader. Business Analysis: Lead enterprise-wide initiatives to gather, analyze, and prioritize business requirements, aligning AI solutions with long-term organizational objectives. Oversee comprehensive analyses of complex business processes, designing AI-driven strategies to achieve operational excellence and competitive advantage. Authorize and review business cases, feasibility studies, and ROI analyses to secure executive approval for transformative AI initiatives. Ensure the creation of high-quality business requirements documents, process flows, and strategic roadmaps to guide enterprise-level AI implementations. Stakeholder Engagement: Act as a key liaison between C-suite executives, technical teams, and external partners, driving alignment on AI strategies and initiatives. Lead enterprise-level workshops, steering committees, and governance boards to shape AI adoption and ensure stakeholder buy-in. Represent the organization in industry forums and partnerships to advocate for AI-driven innovation in life sciences. Team Management and Coaching: Manage/mentor a team of Senior Specialist Business Analysts, providing strategic guidance, setting performance goals, and fostering professional development to ensure high-impact AI business use case delivery. Coach Senior Specialists in advanced business analysis techniques and Generative AI applications, enhancing their ability to address complex challenges in the life sciences domain and ensuring alignment with organizational objectives. Generative AI: Oversee the development and deployment of enterprise-scale Generative AI solutions, ensuring alignment with business needs and technical feasibility.s Collaborate with AI architects and data science leaders to define model architectures and deployment frameworks for life sciences applications. Ensure AI solutions are scalable, reliable, and fully integrated into mission-critical workflows. Regulatory & Compliance: Establish governance frameworks to ensure AI solutions comply with global regulatory standards (e.g., USFDA, EU, PMDA) and ethical principles. Lead risk management efforts, addressing ethical, legal, and operational risks associated with AI deployment in life sciences. Minimum Requirements 10–12 years of core Business Analyst or strategic consulting experience in the life sciences domain with at least 5 years leading AI technologies, supported by a Master’s degree in Life Sciences, Biomedical Sciences, Computer Science, Data Science, or a related field. A PhD or MBA is highly desirable. Expert understanding of Generative AI, machine learning, and their applications in life sciences. Proficiency in advanced data analysis tools (e.g., Python, TensorFlow, Power BI). Exceptional project management skills, with a proven track record of leading enterprise-scale AI projects (e.g., Agile, SAFe, or PMI methodologies). Superior analytical and problem-solving abilities, with a strategic mindset and ability to drive organizational change. Outstanding communication and leadership skills, with the ability to influence C-level stakeholders and lead cross-functional teams. Deep familiarity with life sciences/pharmaceutical regulatory requirements and industry standards. Why consider Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn More Here https://www.novartis.com/about/strategy/people-and-culture Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less

PrimeVigilance (part of Ergomed Group) is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Job Description The Financial Project Analyst has wide ranging responsibilities of PFA related duties. Work with Project Management Team to accurately forecast future units and revenue. Manage the financial health of our projects, working closely with the project to team to accurate record all financial data, report financial data clearly to the Project team. Monitor the total project cash positions. • Responsible for all the financial aspects of assigned projects • Ongoing maintenance of the financial and operational data within the companies’ management information structure • Creation and distribution of scheduled reports • Complete month end responsibilities including revenue recognition and forecasts, variance analysis, profitability analysis, and any other reporting needs as required • Support Proposals & Contracts and Project Directors on the development of financial analysis for proposals • Work closely with the Project Manager to provide on-going financial resource planning, management and analysis • Supports the overall health of assigned projects • Perform ad hoc financial analyses as requested by Project Managers and/or Department Heads Qualifications · BA/BS degree in Business, Accounting, Finance, or equivalent education and experience. · Demonstated relevant finance or accounting experience, project accounting/analysis a plus · Pharmaceutical or CRO experience is preferable · Strong proficiency in English · Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) is essential · Proficiency with accounting software packages · Experience with Oracle Finance is preferred · Knowledge in financial modelling techniques · Excellent analytical skills Additional information We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships Show more Show less

Job Description Regional Medical Advisor (RMA) – General & Specialty Medicine, South 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 company's 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 company's 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 company's 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 Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills 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. Requisition ID R350739 Show more Show less

Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. Job Description Position Summary This role requires working as part of the Safety System Administrator Team performing database administration activities; supporting creation and upgrade of database instances; change control and data migration activities; first line user support and troubleshooting; and training users on databases. Principal Responsibilities The Safety System Administrator is primarily responsible for: Maintenance of database libraries Involvement in system validation activities Interrogating the database and generating outputs for internal and client use Training and providing database access to internal and client users Principle Functions For the Client (may include but is not limited to the following) Set up and maintenance of project specific database libraries including: Products Licenses Studies Reporting destinations Documenting and validating any change to the project specific database Support during legacy data transfer e.g., validation Supporting/providing guidance to the Project Manager / Client / Project Start Up Team during the development of project specific data handling guidelines (to ensure project specific guidelines are necessary and will not impact line listings and report generation) Prepare line listings and tabulations and other database outputs for use in aggregate reports, signal detection, reconciliation and other activities as required Provide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed) Provide database training to clients Providing and documenting client / internal team access upon receipt of an approved access request. For the Company (may include but is not limited to the following) Coordinate user access (including maintenance and revoking access) Maintain database procedures including core data handling conventions Provide database training and certification to PrimeVigilance users Provide user support Involvement in root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with Quality procedures Provide case processing quality and compliance metrics to the Quality Team Identify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc. Execute business continuity periodic testing for database failure Ensure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as required Support IT, database vendor and technical colleagues in troubleshooting and implementing software fixes and enhancements as required Other Supportive Responsibilities Assist PrimeVigilance senior management on an as needed basis. Potentially provide chargeable consulting / training activities to clients regarding Argus, and if required LSSMV. Qualifications Educated to degree standard Demonstrated work experience within Argus Safety Systems. Additional Information Why PrimeVigilance? We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We Offer Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! We look forward to welcoming your application. Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships 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 NoPerformance ParameterMeasure1ProcessNo. 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) . Experience: 1-3 Years . 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 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 NoPerformance ParameterMeasure1ProcessNo. 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 &DrugSafety(Med Device . Experience: 1-3 Years . 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

We are looking for an MSL- Oncology for a Global Pharmaceutical MNC Profile: Medical Science Liaison- Oncology Location: Delhi/ Kolkata (2 openings) Qualification: MD Pharmacology with minimum 6 months of experience in solid cancers MDS/ PhD with minimum 1yr of Oncology experience as MSL/RMA MD Pharmacology with clinical experience in Oncology can apply too Job Purpose: The Medical Science Liaison (MSL) will establish the company’s medical affairs presence with external stakeholders through scientific exchange and research support in oncology. The focus will be on licensed and non-licensed products for hard-to-treat cancers, including metastatic pancreatic cancer, cholangiocarcinoma, digestive cancers (such as stomach cancer, pancreatic cancer, and cholangiocarcinoma), glioma, brain tumors, hematologic cancers (acute myeloid leukemia, acute lymphoblastic leukemia, and lymphoma), and pediatric cancers. This role is field-based, covering the India region. The MSL will communicate balanced therapeutic area-related, product-related, and clinical information to external stakeholders (e.g., physicians, academic institutions, hospital formulary committees), respond to unsolicited requests for medical information, facilitate research discussions, and bring key insights from the medical and scientific community to internal stakeholders. The role also involves ensuring compliance with all company procedures, confidentiality standards, and contributing to business success with a focus on patient safety. Principal Accountabilities: 1. Exchange of Medical and Scientific Information: Responsible for communicating fair and balanced therapeutic area-related, product-related, and clinical information to external stakeholders. Execute the scientific engagement plan in alignment with the Therapy Medical Plan. Proactively develop long-term peer-to-peer relationships with opinion leaders and relevant stakeholders. Respond to unsolicited requests for medical information, including off-label data, related to marketed products and pipeline products. Provide clinical and medical presentations to external stakeholders as needed. Disseminate updates from scientific meetings and report information of strategic interest to cross-functional teams. 2. Supporting Clinical Research: Support ongoing and future Medical Affairs Company-Sponsored Studies, providing country-level review of proposed research site lists, attending site visits if necessary, and providing feedback to the line manager. Support unsolicited requests for investigator-initiated trials (IITs) proposals by offering appropriate investigator support as per company SOPs. Assist in the development and support of national disease registries and Real-World Evidence (RWE) projects as necessary. 3. Contributing to the Organization through Medical Expertise & Market Insights: Maintain up-to-date knowledge of scientific/medical developments in the relevant therapeutic area through literature searches, clinical papers, conferences, and other relevant events. Capture and share in-field insights to develop territorial Field Medical Plans and support medical and scientific strategies. Provide medical and scientific expertise to commercial partners within regulatory guidelines. Act as a field-based scientific and clinical reference for internal stakeholders (e.g., sales, market access) through training and ad-hoc support. 4. Cross-Functional Collaboration: Support the development of medical/scientific materials, ensuring content is reviewed and approved according to company policies. Contribute to the development and execution of the regional medical affairs strategy and action plan in collaboration with field departments such as Sales, Clinical Research, and Market Access. Keep medical representatives and their managers informed about the latest scientific developments. Support the market access strategy at a regional level, including hospital listings, in coordination with the market access manager. 5. Compliance with External Regulations and Company Policies: Maintain a high level of scientific, clinical, and environmental knowledge through courses, self-learning, and attendance at relevant meetings. Stay informed about regulations related to medical information services in the pharmaceutical industry. Ensure all activities comply with internal and external codes of conduct, prioritizing patient safety by following pharmacovigilance processes. Support the company’s reputation in the field by adhering to industry regulations. 6. Patient-In Activities: Support patient awareness initiatives, both physical and digital. Contribute to the Patient-In strategy, understanding the patient journey in coordination with therapeutic area experts, and set up Patient Support Programs (PSPs) to improve patient outcomes as per local regulations. General Administration: Complete all required administration within the specified timelines. Submit monthly reports and expenses by the second working day of each month. Ensure timely completion and submission of all required documentation to the Head Office as appropriate. Profile Requirements A] Minimum Requirements: Education: MBBS/MD Minimum 1-2 years of working experience in oncology. B] Indispensable Qualities: Strong ability to learn new subjects and environments comprehensively. Excellent written and spoken communication and presentation skills, with the ability to build and maintain collaborative relationships with opinion leaders, physicians, and other healthcare decision-makers. Substantial business acumen and autonomy in managing priorities and activities. Strong commitment to compliance with relevant rules and procedures, as well as scientific integrity and quality. Ability to manage cross-functional projects effectively. Leadership skills, emotional intelligence, active listening, and strength of conviction. Negotiation and problem-solving abilities. Proficiency in English is essential. Ability to innovate and execute strategies effectively. Relevant candidates can share their CV at pooja.j@domniclewis.com Show more Show less

The SMW will be responsible for authoring the signal management reports including Validations, SERs, HA requests etc. The scientist will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc. Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO. Conduct/support signal detection and evaluation activities according to SOPs and guidelines Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting Maintaining a good working knowledge of the assigned Clinical studies for narratives Attending/conducting internal, drug safety and project specific training sessions Imparting trainings to the new starts during the induction sessions and the team as required. Skills Analytical and problem-solving skills Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently A flexible attitude with respect to work assignments and new learning Ability to negotiate on behalf of the department to ensure resources, timelines and expectations are aligned Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Fluency in written and spoken English Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point) Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Provides departmental expertise and perspectives to promote prospective business opportunities. Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text Typing and transcription accuracy Knowledge And Experience Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field. Good knowledge of medical terminologies Education Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.) A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage Show more Show less

Job Purpose Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products Signal detection/analysis/evaluation and ongoing safety surveillance activities Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety Function as pharmacovigilance representative/safety scientist General Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and international drug safety regulations Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Maintaining excellent knowledge of the safety profile of assigned products Communicating and discussing issues related to review process with Project Manager Interacting with internal and external contacts for resolving issues Maintaining a good working knowledge of relevant regulatory guidelines Attend and present client/cross functional meetings along with other stakeholders Case report Medical review Performing medical review of cases according to client Standard Operating Procedures (SOPs) and liaising with the client, as required Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Assessing seriousness and expectedness of reported events Providing medical advice to case processing team Skills Excellent interpersonal, verbal and written communication skills Computer proficiency, an ability to work with web-based applications and familiarity with the Windows operating system Client focused approach to work A flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential Willingness to work in a matrix environment and to value the importance of teamwork Strong knowledge of international drug regulation including GCP, GVP Knowledge And Experience Good knowledge of medical terminology. Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred. Education MBBS/MD Show more Show less

Key Responsibilities Deliver training sessions on Clinical Research, GCP (Good Clinical Practice), Regulatory Affairs, Pharmacovigilance, and related topics Design, update, and improve training materials, presentations, and assessments Assess and evaluate trainees' understanding through tests, assignments, and practical exercises Stay updated with the latest industry trends, guidelines, and regulatory changes Conduct both classroom and online training sessions as per company requirements Provide career guidance and mentoring to students/professionals Collaborate with industry experts to enhance training effectiveness Requirements Minimum 1 year of experience in clinical research / clinical trials / Pharmacovigilance or a related field Strong knowledge of ICH-GCP, CDSCO, USFDA, EMA, and other global regulatory guidelines Excellent communication and presentation skills Experience in training, mentoring, or teaching is an advantage Ability to engage and interact effectively with learners Proficiency in using LMS (Learning Management Systems) and online training platforms is a plus About Company: PMCTI stands for Pune Medical Coding Training Institute. We are a leading provider of medical coding training in Pune, India, dedicated to empowering individuals with the knowledge and skills necessary to thrive in this dynamic and rewarding healthcare field. Our team is comprised of passionate and experienced professionals who share a deep commitment to education and excellence. We boast certified trainers with extensive industry experience, who are equipped to guide and mentor aspiring medical coders. We believe in fostering a supportive and collaborative learning environment where students can acquire valuable knowledge, build confidence, and achieve their career goals. Show more Show less

Job Overview Provide leadership for Lifecycle Safety, Service Operations (SO), developing cross-functional integrated delivery plans for safety operations throughout all stages of the Lifecycle Safety opportunity chain. Provide leadership for a combination of designated Lifecycle safety operations service lines and direction for specified accounts. Participate actively in local and global initiatives, as needed. Provide line management for assigned staff who are deployed in Service Operations. Primary point of contact for assigned customers or account Essential Functions Accountable to monitor and track project financials/ budget to ensure agreed margins are maintained Independently engage assigned customers on escalation, scope expansion and look for additional business opportunities Lead a high quality and efficient Service Operations team. Develop and review the team reporting structure for IQVIA while adhering to governing standard operating procedures (SOPs), work instructions and applicable regulatory guidelines and regulations. Accountable to meet all project specific SLA and KPI’s Direct and support operational decisions in collaboration with senior management. Ensures financial project performance through oversight of key performance metrics. (revenue, direct costs, time-sheet costs, utilization and realization). Act as mentor and coach to less experienced managers, as appropriate. Lead and support ongoing overarching operational, strategic and tactical initiatives as assigned/ agreed, ensuring timely and complete delivery. Direct project resource assignments including staff hiring, and training in collaborations with senior management. Direct and/or participate in cross-functional teams and other process improvement initiatives. Lead and anticipate actively in local and global initiatives, as needed. Support in designing functional strategy Demonstrate and cascade the organizational vision and mission, core values Ability to independently participate in Request for proposal (RFP) and bid defense Ability to represent IQVIA in various industry forums and conference as required Qualifications Bachelor's Degree Scientific or healthcare discipline or allied life sciences Bachelor’s degree in health science or related area, and 15 years experience in Contract Research Organization or Pharmaceutical company or life science services company, including 10 years of experience in managing a workforce of up to 400+ employees, operating with senior/executive management teams or equivalent combination of education, training and experience. Ability to clearly articulate to large group and build consensus. Ability to address large audience during townhalls and other external forums. Excellent interpersonal skills, effective communication. Engagement with global delivery hubs. In-depth knowledge of Safety service lines. willingness to increase knowledge across Safety service lines and develop new skills. Proven Staff management skills, strong leadership, motivational and influencing skills. Ability to work on multiple projects and manage competing priorities. Effective mentoring and developed coaching skills. Excellent presentation, report writing skills and customer focus skills. Ability to achieve results through communication and facilitation in a matrix service delivery environment with shared accountabilities. Sound judgment, decision-making and problem solving skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to support in drafting SOP, Operation, Technical Project documents. Ability to understand and analyze performance Metrix and numbers to support operations. End to End Project management exposure. Excellent team leadership and customer services skills. strategic customer focus. Strategic understanding of business processes across opportunity chain and all phases of product lifecycle. Strong analytical, judgment and decision-making skills. Strong innovation/solution skills. Strong communication (written and verbal) and presentation skills. Strong problem-solving, influencing, negotiation, conflict management and collaboration skills. Highly effective time management and delegation skills, ability to manage multiple competing priorities, meet multiple demanding timelines and work creatively in fast-paced environment. Strong ability to deliver results to the appropriate productivity, budgetary and quality metrics. Demonstrated flexibility, initiative, proactivity, ownership and accountability. In depth knowledge of and ability to apply GCP/ICH/Good Pharmacovigilance Practice and applicable regulatory guidelines. Strong ability to establish and maintain effective working relationships with coworkers, managers and customers. - Extensive use of keyboard requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time. May require occasional travel. Flexibility to operate in shifts. Flexibility to support in global time zones as required. 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

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent thats bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegenes high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. Job Responsibilities Act as SME for safety business and track industry trends relevant to safety Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions Responsible for improving capability presentations and identifying service areas and solutions and work with the operational leadership to build capabilities Participate in the analysis and definition of efficient, cost-effective and creative solutions that deliver competitive value propositions to the industry Build partnerships with senior leadership across the industry in Safety and PV Represent the company in trade conferences, speaker sessions, etc. Identify and build potentially synergistic partnerships to expand client and service footprints Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed Must Have MBBS/MD with a minimum of 8-10 years of experience in drug safety or a related field; Master/Diploma in Management degree is an added advantage Experience in the pharmaceutical industry, preferably in drug safety, pharmacovigilance, or clinical development Knowledge of pharmacology, toxicology, and clinical trial methodology Understanding of FDA and international regulatory requirements related to drug safety and pharmacovigilance Strong analytical and problem-solving skills Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams Demonstrated ability to prioritize tasks and manage multiple projects simultaneously Proficiency in data analysis tools (e.g., Excel, SAS) and safety databases (e.g., Argus, ARISg) Good communication skills and relationship building skills Good to Have Equal Opportunity Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidates merit, and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics. Locations Bangalore, KA, IN Show more Show less

Job Summary The TM-Pharmacovigilance role involves ensuring the safety and efficacy of pharmaceutical products through vigilant monitoring and analysis. With a focus on regulatory intelligence the candidate will contribute to maintaining compliance and enhancing customer service. This hybrid role requires rotational shifts and proficiency in English with no travel obligations. Responsibilities Monitor and analyze adverse drug reactions to ensure patient safety and product efficacy. Collaborate with cross-functional teams to gather and interpret regulatory intelligence data. Provide expert guidance on pharmacovigilance processes to enhance customer service experiences. Develop and implement strategies for effective risk management and mitigation. Ensure compliance with global regulatory standards and guidelines in pharmacovigilance activities. Oversee the preparation and submission of regulatory reports and documentation. Conduct thorough research to support the development of new pharmacovigilance methodologies. Facilitate communication between stakeholders to ensure seamless regulatory affairs processes. Utilize advanced analytical tools to assess and improve pharmacovigilance systems. Lead initiatives to optimize research and development efforts in drug safety. Support the integration of regulatory intelligence into strategic planning and decision-making. Drive continuous improvement in pharmacovigilance practices to benefit public health. Maintain up-to-date knowledge of industry trends and regulatory changes. Qualifications Possess strong expertise in customer service within the pharmacovigilance domain. Demonstrate proficiency in regulatory intelligence and its application in drug safety. Have experience in regulatory affairs and research and development as a nice to have skill. Exhibit excellent communication skills in English both written and spoken. Show ability to work effectively in a hybrid work model with rotational shifts. Display a commitment to maintaining high standards of compliance and safety. Bring a proactive approach to problem-solving and process improvement. Certifications Required Certified Pharmacovigilance Professional Regulatory Affairs Certification - B.Pharm/M.Pharm

SUMMARY Job Title: SAR & SAR-like Patient Safety Physician Reporting To: Patient Safety Physician SAR & SAR-like Coordinator Minimum Educational Qualifications and Experience Required Skills Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Operational Responsibilities Compile PBRERs with a focus on medical aspects and safety sections of products, and analyze safety trends, including source data analysis based on queries Assist in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborate with Therapeutic Head to identify signals and address product safety concerns Engage with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensure 100% compliance with timely completion of all client and Cognizant required trainings Achieve 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities