Head Pharmacovigilance & Medical Affairs

Role Summary

Head Pharmacovigilance & Medical Affairs responsible for leading Pharmacovigilance and Medical Affairs including medical information for Dr. Reddy’s North America Generics and affiliates and Dr. Reddy’s Canada. Drive Medical Affairs strategies and ensure accurate patient safety data, oversight of medical information services, and provide strategic inputs to cross-functional teams while initiating, improving, and monitoring existing systems.

Responsibilities

• Manage, create (vendor) and review ICSR (US/Foreign), PSR reports from clinical and medical perspectives; identify and respond to signal analysis; submit to regulatory agencies (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norms
• Anchor drug safety regulatory inspections in the US; participate in audits; drive PV audits to no critical findings and provide post-inspection reports with corrective action plans
• Identify pharmacovigilance processes and procedures to be documented; establish the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements
• Review reporting periods against historical data to evaluate risks; assess safety risks of existing products; generate risk-benefit reports and develop regulatory proposals; manage REMS program, budget, and ensure regulatory sign-off with corrective actions as needed
• Support development and execution of North America Medical Affairs plans and Dr. Reddy‚Äôs Canada Medical Affairs plans aligned with clinical best practices and corporate objectives
• Provide oversight of medical information services for North America and ensure seamless communication with PV service providers
• Engage cross-functionally to maximize reporting relationships and implement company strategies; support scientific congress attendance with pre-meeting planning and post-meeting CI reporting
• Support global Pharmacovigilance digitalization to increase efficiency, quality, and productivity while ensuring 21CFR Part 11, GAMP 5 and GxP compliance

Qualifications

• Educational qualification: Advanced scientific degree (MD, PhD, Pharm.D. or equivalent)
• Minimum work experience: 10+ years in PV & Medical Affairs in the pharmaceutical industry

Skills

• Understanding of North American pre- and post-marketing regulatory requirements for Medical Affairs and Medical Information
• Knowledge of FDA and Health Canada processes across Drug Discovery and Development, Clinical Development Tools, Medical Affairs Guidelines, Regulatory and Pharmacovigilance Guidelines
• Collaborative team player able to work across teams and functions
• Proactive with strong attention to detail
• Excellent verbal and written communication; proficiency in MS Office
• Ability to manage multiple projects, solve problems, deliver on commitments, and work with multidisciplinary teams

Education

• Advanced scientific degree (MD, PhD, Pharm.D. or equivalent)

Additional Requirements

• Must be a U.S. citizen or lawful permanent resident of the U.S. or otherwise authorized to work in the U.S. without visa transfer or sponsorship