Pharmacovigilance Jobs in Mumbai

Job Description Country Medical Director, India THE OPPORTUNITY The Country Medical Director (CMD) is the Senior Medical Leader for Our Company in a country and serves as the leader of the medical affairs organization in their geography Based in Mumbai, named one of the Best Companies for Women in India by Avatar, 2019. Join the premier biopharmaceutical company that has been in Asia Pacific for over 60 years We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio. WHAT YOU WILL DO: CMD is the primary country level contact for Medical Affairs (MA) and has the following key responsibilities: Develops and executes the MA strategy for the country Creates and maintains a high-performing, highly compliant MA organization for the country Manages the entire portfolio for Our Company allocates resources balancing global and local priorities Represents Medical Affairs in the Country Leadership Team and in cross-functional collaborations with other Research & Development functions, Human Health (HH), and others Communicates accomplishments, opportunities, and needs of the country/cluster to regional and/or global stakeholders Represents Our Company in external activities requiring the leadership and expertise of the country s Senior Medical Leader Responsibilities and Primary Activities: Leadership and Management of the Medical Affairs Organization People Proactively manages and develops talent Proactively identifies new opportunities and gaps vs. emerging needs and addresses in a timely manner by reallocating and training of existing staff and/or external recruitment Creates an empowering, compliant, collaborative, and innovation-focused work environment Builds a culture of quality and compliance through training, oversight, and collaboration Country Medical Affairs Plans (CMAPs) Strategically develops, executes, and delivers CMAPs, including tactical deliverables for each therapeutic area, such as post-licensure research, publication plans, investigator-initiated studies, and other knowledge transfer activities Ensures alignment of the CMAPs with global strategy and adherence to all relevant regulations, Policies and Standard Operating Procedures (SOPs) Manages the country-developed Protocol Concept Sheets (PCS), obtains regional and global approvals for new local data generation activities, and manages their execution Medical Affairs Management Provides oversight to the country medical information team, establishes processes and systems to ensure that medical information requests (MIRs) from healthcare professionals are addressed in a timely manner and in alignment with the global scientific response documents and training materials Manages approved operating administrative (e.g., salaries & travel) and life cycle management budget (e.g., advisory boards, local data generation, etc.) Oversees all activities of local medical department employees Oversees inspections and inspections audits, answering inquiries by health authorities, ethical committees, and internal auditors in conjunction with Regulatory, Pharmacovigilance (PV) and Global Clinical Trial Operations (GCTO) Collaboration with Key Internal Stakeholders The CMD represents Medical Affairs in cross-functional leadership teams and collaborations and advocates for the interests of the country (or cluster) with regional and global colleagues Country (or Cluster) Leadership Team Represents Medical Affairs and is the medical voice in the country (or cluster) executive management team Global Clinical Development (GCD), Global Clinical Trial Operations (GCTO), and Global Clinical Scientific Affairs (GCSA) Supports GCTO when requested Manages the submission and our Research & Development Division roles in the conduct of investigator-initiated studies. Leads country review of Compassionate Use Requests and Pre-License Patient Access (PLPA) programs and facilitates Chief Medical Officer (CMO) approval of these requests Center for Observational and Real-World Evidence (CORE), Market Access, Regulatory Affairs, HH, and Policy Interacts with CORE, Market Access, and Global Medical Affairs experts to develop and manage observational, real-world effectiveness and epidemiologic studies Collaborates with CORE, market access, regulatory and commercial colleagues by providing scientific expertise and managing the medical aspects of submissions for regulatory, reimbursement or tenders for Our company's entire portfolio of medicines and vaccines Provides medical expertise to the commercial product teams, ensuring the scientific and medical value of Our Company's products across all therapy areas Engagement with Key External Stakeholders The CMD represents Our Company as an executive leader and scientific expert to the external community. Serves as external interface with key stakeholders, insurers/government leaders, selected professional societies, medical-scientific institutions, and the broader scientific community to lead and execute the medical research and implementation strategy for Our company s innovative medicines, ensuring that the medical community is appropriately engaged with the information they need to support patient care needs (e.g., scientific advisory boards, scientific leader (SL) engagements, webin...

Job Description Job Title: Medical Advisor Job responsibilities: To actively contribute to the organization/business unit (BU)/TA cluster by taking responsibility for the scientific, technical and ethical soundness of all policies, statements and endeavors. To lead the BU medical team in all activities medically related to the allocated Pfizer Business Unit portfolio and provide high quality and timely service in the areas of medical initiatives/support to the assigned portfolio, Interactions with Healthcare Professionals, Continuing Medical Education, Clinical Research, Sales Force Training, Medical Information, and Performance/People Management, and support in the areas of New Product Development/ Branded Value Offerings, Regulatory Affairs, Quality Standards, and Business Technology A. Strategic/Policy: Provide tactical and strategic inputs, and business/technical expertise, to Product Management towards ethical promotion of assigned products, in the operational areas listed B. Operational: Medical Initiatives/support for the Allocated Portfolio (New/Key Detail/In-line Products) Provide strategic inputs and support towards creation of marketing/brand plans/medical development plans, and towards design and execution of medical-marketing programs/clinical programs, including initiatives to enhance access to medicines Initiate and/or review and/or approve promotional, training, and Continuing Medical Education (CME) material in compliance with relevant SOPs/regulations/industry codes/working practices Participate/facilitate/conduct customized promotional/educational interactions with Health Care Professionals (HCPs). These interactions include, but are not limited to, customer launch meetings, advisory boards, CME programs, scientific symposia, institutional presentations, etc. C. Clinical Research : In consultation with concerned stakeholder/vendor/interface, develop/write and/or review and/or approve protocol synopsis/final protocols/supporting documents per need (e.g., investigators brochure (IB), informed consent form (ICF), patient information sheets, etc.) for, Phase IV, PMS, Observational studies / surveys, Pharmacoeconomic / Outcomes Research studies, and other clinical projects / programs. In consultation with concerned stakeholder/vendor/interface, review and approve additional supporting documents/databases including ICF/CRF/SAP, etc. Assist in planning, organizing and preparing Investigational New Drug Applications (NDAs) Review/interpret data generated; write final reports for locally sponsored studies as required Develop and execute Publication Plan; review/approve/write manuscripts for publication of locally sponsored studies Develop and execute Information Dissemination Plan/Program Medical Information Provide useful, timely, accurate, and balanced medical information to internal (sales staff) and external (HCPs) customers, in adherence to relevant SOPs/policies D. Sales Force Training: Provide medical training to new sales staff on basic sciences/ TAs/assigned products. Provide refresher training to sales staff through ongoing training initiatives Provide pre-launch and launch training to sales staff for new products E. New Product Planning/Development: For global products, assist NPP team with preparing business case, and pre-commercialization programs/initiatives/activities to prepare internal and external stakeholders for new product launches. These include assistance with market research, stakeholder mapping, and early access programs Support New Product Planning, Marketing, and Business Development colleagues with medical evaluation and recommendations on opportunities to launch new products (e.g., licensing, acquiring, co-promotion, etc.) Support organization efforts at developing local formulations/line extensions through literature search/recommendations. Function as custodian for coordinating internal and regional approvals through the RFD (Request For Development) process F. Regulatory: Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication. Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc.) Write, revise, and review labeling documents for pipeline/local products per relevant SOPs Provide medical support towards processing of spontaneous/solicited AE reports, per relevant SOPs and/or working practices Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical