Head Pharmacovigilance & Medical Affairs

Head Pharmacovigilance & Medical Affairs We are seeking an exceptional leader to head Pharmacovigilance and Medical Affairs, including the medical information function, for Dr. Reddy’s North America Generics and affiliates as well as Dr. Reddy’s Canada. The incumbent will drive Medical Affairs strategies and be responsible for accurate patient safety data. Provide oversight of medical information services and support in providing strategic inputs to cross-functional teams, and initiate, improve, and monitor the execution of existing systems. Responsibilities Manage, create and review ICSR (US/foreign) and PSR reports from clinical/medical perspectives; identify and respond to signal analyses; submit to regulatory agencies (FDA/Health Canada) within timelines to achieve regulatory compliance. Lead drug safety regulatory inspections in the US (FDA); participate in audits; support external audits; drive PV audits to achieve no critical findings and provide post-inspection corrective action plans. Identify pharmacovigilance processes and procedures to document and set up; establish the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements. Review current reporting periods against historical data to evaluate risks, identify risk areas, assess safety risks, develop risk-benefit analyses, and manage REMS programs, budgets, and regulatory sign-offs with corrective actions when needed. Support the development and execution of North America Medical Affairs plans and Canada Medical Affairs plans in line with best clinical practices and corporate objectives aligned with brand strategy. Provide oversight of North America medical information services and ensure seamless communication with Pharmacovigilance service providers. Engage cross-functionally to maximize reporting relationships and ensure successful implementation of company strategies; support scientific congress attendance with pre-meeting planning and post-meeting CI reporting. Support global Pharmacovigilance digitalization efforts to improve efficiency, quality, and productivity while ensuring deliverables comply with 21 CFR Part 11, GAMP 5 and GxP. Incumbent should be willing to work in person from our Princeton, NJ office. Qualifications Educational qualification: Advanced scientific degree (MD, PhD, Pharm.D. or other) Minimum work experience: 10+ years in PV & Medical Affairs in the pharmaceutical industry Skills & attributes: Understanding of North American pre- and post-marketing regulatory requirements for medical affairs and medical information activities. Knowledge of FDA and Health Canada: Drug Discovery and Development Processes; Clinical Development Tools and Processes; Medical Affairs Guidelines; Regulatory Guidelines; Pharmacovigilance Guidelines; domains across the pharma value chain. A collaborative team player with ability to work successfully across teams and functions. Proactiveness with attention to detail. Excellent communication skills (verbal and written); MS Office suite. Demonstrated ability to manage multiple projects, solve problems, deliver on commitments, and work with multidisciplinary teams. Additional Information Must be a U.S. citizen or lawful permanent resident of the U.S. or otherwise authorized to work in the U.S. without requiring visa transfer or sponsorship, now or in the future. Dr. Reddy's Laboratories offers a competitive total rewards package including base salary determined on role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day: Good Health Can’t Wait. This credo guides our actions as we work to help patients lead healthier lives, foster empathy and dynamism, and value teamwork and shared success. Equal Opportunity Employer An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. Seniority level Executive Employment type Full-time Job function Other Industries Pharmaceutical Manufacturing For more details, please visit our career website at #J-18808-Ljbffr