About the job
Join Dr. Reddy's as the Director of Pharmacovigilance for North America, where you will lead a pivotal function within our organization. This role involves overseeing medical affairs and medical information services while providing strategic insights to cross-functional teams. Your leadership will drive the enhancement and execution of pharmacovigilance systems that ensure compliance and excellence.
Based in Princeton, NJ, you will report directly to the Global Head of Pharmacovigilance.
Key Responsibilities:
- Establish and maintain robust pharmacovigilance processes in alignment with US regulatory requirements, ensuring documentation and quality management.
- Stay abreast of changing North American pharmacovigilance regulations and communicate necessary adjustments to Global Pharmacovigilance (GPV).
- Ensure compliance with regulations regarding adverse event intake, processing, submissions, and quality of Individual Case Safety Reports (ICSRs).
- Collaborate with USFDA and Health Canada on all pharmacovigilance and product safety matters.
- Notify GPV of any changes in the product portfolio, including new approvals and updates to Prescribing Information (PI).
- Alert GPV about significant safety concerns in the region and manage local pharmacovigilance services effectively.
- Lead regulatory inspections and audits, ensuring no critical findings and developing corrective action plans as needed.
- Analyze historical data to evaluate risks, propose regulatory adjustments, and manage the Risk Evaluation and Mitigation Strategies (REMS) program.
- Support the formulation of Medical Affairs plans aligned with corporate objectives and brand strategies.
- Oversee medical information services, ensuring effective communication with pharmacovigilance service providers.
- Facilitate cross-functional collaboration and support scientific congress attendance through detailed planning and reporting.