Head – Pharmacovigilance & Medical Affairs | Princeton, NJ, USA
Location: Princeton, New Jersey, USA
Department: Pharmacovigilance & Medical Affairs – North America & Canada
Employment Type: Full-Time | On-site
Experience Required: 10+ years in Pharmacovigilance and Medical Affairs in the pharmaceutical industry
Function: Drug Safety, Regulatory Compliance, Medical Strategy, Medical Information
About Dr. Reddy’s Laboratories
At Dr. Reddy’s Laboratories, our mission is “Good Health Can’t Wait”. As a global pharmaceutical leader, we are dedicated to making medicines more affordable, discovering innovative therapies, and meeting unmet medical needs to help patients lead healthier, longer lives.
We are committed to diversity, equity, and inclusion, creating a workplace where everyone belongs, thrives, and contributes to the team’s success. Our North America and Canada operations focus on delivering high-quality generics and specialty medicines while adhering to the highest standards of patient safety and regulatory compliance.
Position Overview
Dr. Reddy’s is seeking a strategic, experienced leader to head Pharmacovigilance and Medical Affairs across North America and Canada. This role includes oversight of patient safety data, medical information services, and the execution of Medical Affairs strategies in alignment with commercial and clinical objectives.
The ideal candidate will have extensive knowledge of North American regulatory requirements, proven leadership experience, and the ability to collaborate across cross-functional teams.
Key Responsibilities
Pharmacovigilance Leadership:
Oversee the management, creation, and review of ICSRs (US/foreign), PSR reports, and signal analysis for submission to FDA and Health Canada, ensuring 100% compliance with regulatory requirements
Lead regulatory inspections and audits, including FDA inspections, and drive successful outcomes with corrective action plans
Establish and maintain a Pharmacovigilance Quality Management System (QMS) compliant with US regulations
Evaluate product safety risks, conduct risk-benefit analysis, and manage REMS programs with regulatory sign-off
Medical Affairs Leadership:
Develop and execute North America and Canada Medical Affairs plans, ensuring alignment with clinical best practices and corporate strategy
Provide oversight for medical information services, ensuring seamless communication with pharmacovigilance providers
Support cross-functional initiatives, scientific congress attendance, pre- and post-meeting reporting, and medical insight generation
Drive digitalization initiatives in Pharmacovigilance to enhance efficiency, quality, and compliance
Strategic & Operational Responsibilities:
Serve as a trusted scientific leader across therapeutic areas, guiding cross-functional teams
Ensure alignment of all activities with COBE (Code of Business Ethics) policies and regulatory compliance
Mentor and lead teams in Medical Affairs and Pharmacovigilance to maintain high performance standards
Collaborate with stakeholders to identify unmet needs, optimize patient outcomes, and support new product development
Required Qualifications
Education:
Advanced scientific degree (MD, PhD, Pharm.D., or equivalent)
Experience:
Minimum 10+ years in Pharmacovigilance and Medical Affairs within the pharmaceutical industry
Proven experience in North American regulatory compliance (FDA, Health Canada)
Demonstrated leadership in drug safety, medical strategy, and team management
Skills & Competencies:
Deep understanding of US and Canadian pre- and post-marketing regulations for Medical Affairs and Medical Information
Expertise in clinical development, pharmacovigilance guidelines, medical affairs operations, and cross-functional collaboration
Strong analytical, strategic, and decision-making abilities
Exceptional communication, interpersonal, and leadership skills
Proactive, detail-oriented, and capable of managing multiple projects and stakeholders
Work Authorization:
Must be a U.S. citizen, lawful permanent resident, or otherwise authorized to work in the U.S. without visa sponsorship
Benefits & Work Culture
Competitive total rewards package including base salary, annual discretionary bonus, health coverage, retirement savings plans, and leave benefits
Opportunities for professional growth, leadership development, and skill advancement
Dynamic, collaborative, and inclusive work environment
Be part of a mission-driven organization committed to improving patient outcomes and global healthcare
At Dr. Reddy’s, Good Health Can’t Wait is more than a motto—it drives every action, innovation, and patient-focused initiative. Join us in shaping the future of Pharmacovigilance and Medical Affairs in North America and Canada.
Apply now: Dr. Reddy’s Careers
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