QUALIFICATION

Masters Degree

JOB DESCRIPTION

Job Title: Head – Pharmacovigilance & Medical Affairs

JOB SUMMARY:

We are seeking a Head of Pharmacovigilance & Medical Affairs to lead and oversee pharmacovigilance operations, regulatory compliance, and medical affairs strategy for North America. The role involves managing drug safety, ensuring regulatory adherence, supporting audits and inspections, and providing medical oversight while aligning with corporate and commercial strategies.

QUALIFICATIONS:

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (MD, PharmD, PhD preferred).
• Proven experience in pharmacovigilance, drug safety, and medical affairs leadership roles.
• In-depth knowledge of US and Canadian regulatory requirements (FDA, Health Canada).
• Strong experience managing regulatory inspections, audits, and pharmacovigilance compliance.
• Demonstrated expertise in risk assessment, REMS management, and QMS implementation.
• Excellent cross-functional collaboration, communication, and leadership skills.
• Experience with digital transformation initiatives in PV systems preferred.

KEY RESPONSIBILITIES:

• Manage, create, and review ICSR (US/Foreign) and PSR reports, ensuring timely submission to FDA/Health Canada to maintain 100% compliance with pharmacovigilance regulations.
• Lead drug safety regulatory inspections in the US, anchor FDA audits, and provide corrective action plans post-inspection.
• Establish and manage the Pharmacovigilance Quality Management System (QMS) to meet US regulatory requirements.
• Conduct detailed risk evaluations by comparing current reporting periods with historical data; assess product safety risks and manage REMS programs with regulatory agencies.
• Support development and execution of North America Medical Affairs and Dr. Reddy’s Canada Medical Affairs plans, aligning with brand and corporate objectives.
• Oversee medical information services for North America and maintain seamless collaboration with pharmacovigilance service providers.
• Partner cross-functionally to support scientific congress participation, pre-meeting planning, and post-meeting competitive intelligence reporting.
• Drive pharmacovigilance digitalization efforts to enhance efficiency, ensure compliance with 21CFR Part 11, GAMP 5, and GxP standards.