Position Details
Job Title: Head – Pharmacovigilance & Medical Affairs (North America & Canada)
Department: Global Pharmacovigilance & Medical Affairs
Location: Princeton, New Jersey, USA
Job Type: Full-time | On-site | Leadership Role
Reporting To: Head, Global Medical & Pharmacovigilance
Eligibility: Must be a U.S. citizen or lawful permanent resident or otherwise authorized to work in the U.S. without sponsorship
Job Summary
We are seeking an exceptional leader to head Pharmacovigilance (PV) and Medical Affairs, including the Medical Information function for Dr. Reddy’s North America Generics and affiliates, as well as Dr. Reddy’s Canada.
This role is accountable for driving Medical Affairs strategies, ensuring the accuracy and integrity of patient safety data, providing oversight of medical information services, and offering strategic inputs to cross-functional teams. The incumbent will play a pivotal role in establishing, improving, and monitoring pharmacovigilance systems to ensure compliance with U.S. and Canadian regulatory requirements.
Roles & Responsibilities
Pharmacovigilance Leadership
Lead creation, management, and review of ICSR (US/Foreign) and PSR reports from clinical and medical perspectives.
Identify and analyze safety signals; ensure submission to regulatory agencies (FDA/Health Canada) within defined timelines to achieve 100% compliance.
Anchor drug safety regulatory inspections in the U.S., manage FDA interactions, and lead successful PV audits with no critical findings.
Establish and maintain a robust pharmacovigilance Quality Management System (QMS) compliant with U.S. regulations.
Conduct risk evaluations by comparing current and historical safety data, managing REMS programs, budgets, and corrective actions.
Medical Affairs Strategy
Develop and execute North America and Canada Medical Affairs plans aligned with corporate and commercial strategies.
Oversee Medical Information Services, ensuring scientific accuracy, consistency, and timely communication with internal and external stakeholders.
Support scientific congress participation through pre-meeting planning and post-meeting competitive intelligence (CI) reporting.
Collaborate cross-functionally to align medical strategies with regulatory, clinical, and commercial priorities.
Compliance & Continuous Improvement
Lead pharmacovigilance process digitalization initiatives to enhance efficiency, data integrity, and compliance with 21 CFR Part 11, GAMP 5, and GxP standards.
Drive process improvements, monitoring of existing systems, and proactive identification of compliance gaps.
Provide strategic input into cross-functional teams to ensure data-driven decision-making in product safety and medical affairs.
Regulatory & External Interface
Manage inspection readiness, external audits, and communication with U.S. and Canadian regulatory authorities.
Review safety and risk data, preparing benefit-risk assessments and proposals for regulatory submission.
Team Leadership
Provide vision, mentorship, and leadership to cross-functional PV and Medical Affairs teams across the region.
Foster collaboration, accountability, and scientific excellence within internal teams and with external partners.
Qualifications
Education
Advanced scientific degree (MD, PhD, Pharm.D., or equivalent) — mandatory
Experience
Minimum 10+ years of experience in Pharmacovigilance and Medical Affairs within the pharmaceutical industry
Proven track record of leading cross-functional teams and managing regulatory interactions in North America
Skills & Attributes
Technical Skills
Strong understanding of North American pre- and post-marketing regulatory requirements for Medical Affairs and Pharmacovigilance.
Expertise in FDA and Health Canada regulations, Drug Discovery and Development, Clinical Development, and Medical Information systems.
Proficiency in PV Quality Systems, REMS management, GxP, and digital compliance standards.
Behavioral Competencies
Strategic thinker with excellent leadership and decision-making skills.
Exceptional communication skills (verbal and written).
High level of accountability, proactiveness, and attention to detail.
Demonstrated ability to manage complex projects and deliver results in a cross-functional environment.
Additional Information
Compensation & Benefits
Dr. Reddy’s Laboratories offers a competitive total rewards package, including:
Base salary commensurate with role, experience, and location
Annual discretionary bonus eligibility
Comprehensive healthcare coverage
Retirement savings plan
Paid leave and life coverage benefits
Our Work Culture
At Dr. Reddy’s, our credo “Good Health Can’t Wait” drives everything we do. We are committed to advancing healthcare solutions that help patients lead healthier lives.
Our culture is built on empathy, innovation, teamwork, and integrity. We believe that when diverse minds collaborate toward a shared vision, extraordinary outcomes follow.
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Kyiv |Lima Region :
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