PV Physician - Medical Assessment

Role Overview: As a PV Physician at Dr. Reddy's Laboratories Ltd., you will be primarily responsible for overseeing and providing medical input for benefit-risk assessment activities. Your role will involve ad hoc data analysis, preparation and review of aggregate reports, signal detection and evaluation, support for benefit-risk evaluation efforts, and more. Your contribution will be crucial in ensuring the safety and efficacy of pharmaceutical products. Key Responsibilities: - Ensure quality control of medical assessment of individual case safety reports, including coding, seriousness, expectedness, and company causality assessments conducted by the vendor. - Contribute to scheduling of aggregate reports, RMPs, and other safety-related documents to ensure timely documentation on the report calendar. - Provide medical input and/or review of aggregate reports such as PSUR, PBRER, PADER, Annual Reports, DSURs, and ACOs. - Conduct peer quality review of aggregate reports and reports generated by the vendor. - Support PV Scientists in preparing, reviewing, and submitting aggregate reports in compliance with regulatory requirements. - Provide medical input to signal management activities, ensuring timely signal detection and appropriate actions are taken for confirmed signals. - Review and provide medical input to RMPs, REMS activities, Health Hazard Evaluations, and other safety reports. - Contribute to the identification and design of risk minimization measures in collaboration with PV Scientists and other stakeholders. - Provide medical/safety input to cross-functional documents, participate in clinical and regulatory activities, and support commercial, marketing, and Medical Affairs activities. - Review labelling documents to ensure accurate safety information is present. - Manage Regulatory Authority queries related to pharmacovigilance and coordinate responses with stakeholders. - Participate in due diligence activities for product acquisitions/divestments, CAPA development, and regular meetings with PV team/service providers. - Support the development and revision of department SOPs and participate in PV training for new members and non-PV personnel. Qualifications: - MBBS/MD with 2 years of experience in pharmacovigilance, including ICSRs, Aggregate Reports, or Signal Management. Note: Additional details about the company's Global Manufacturing Organisation (GMO) and benefits offered can be found on the career website at https://careers.drreddys.com.,