Head – Pharmacovigilance & Medical Affairs (North America & Canada)
Location: Princeton, NJ (Onsite)
Company: Dr. Reddy’s Laboratories
Company Description
At Dr. Reddy’s Laboratories, our credo “Good Health Can’t Wait” guides everything we do. We are committed to accelerating access to affordable and innovative medicines that enable patients to lead healthier lives.
Diversity, Equity & Inclusion
We are dedicated to fostering a diverse, equitable, and inclusive workplace where everyone belongs, is valued, and can contribute fully. We welcome applicants from all backgrounds, including those with less traditional career paths.
Position Overview
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, affiliates, and Dr. Reddy’s Canada.
This role involves driving Medical Affairs strategies, ensuring patient safety data accuracy, overseeing medical information services, providing strategic cross-functional inputs, and leading improvements in PV systems and compliance.
Key Responsibilities
Pharmacovigilance Leadership
Manage, create, and review ICSR (US/Foreign), PSR reports, and ensure 100% compliance with FDA/Health Canada regulations.
Lead signal detection, evaluation, and reporting to regulatory agencies within required timelines.
Anchor and manage drug safety regulatory inspections (FDA/Health Canada) and external audits, ensuring no critical findings and driving corrective action plans.
Establish and maintain the Pharmacovigilance Quality Management System to meet US regulatory standards.
Conduct risk evaluations by comparing current vs. historical reporting periods, reviewing product safety risks, and preparing regulatory submissions.
Manage Risk Evaluation and Mitigation Strategies (REMS), including budgeting, implementation, and corrective actions.
Medical Affairs & Medical Information
Develop and execute Medical Affairs plans for North America and Canada, aligning with corporate and brand strategies.
Provide oversight of Medical Information services, ensuring seamless collaboration with PV service providers.
Support scientific congress participation, including pre-conference planning and competitive intelligence reporting.
Ensure compliance with pre- and post-marketing regulatory requirements for Medical Affairs and Medical Information.
Strategic & Cross-Functional Collaboration
Serve as a strategic partner to cross-functional teams, maximizing alignment and execution of company strategies.
Support global PV digitalization initiatives to enhance efficiency, quality, and compliance with 21CFR Part 11, GAMP 5, and GxP standards.
Qualifications
Education
Advanced scientific degree: MD, PhD, Pharm.D., or equivalent.
Experience
10+ years of progressive leadership experience in Pharmacovigilance and Medical Affairs within the pharmaceutical industry.
Skills & Attributes
Strong knowledge of FDA and Health Canada regulations, including:
Drug discovery & development
Clinical development processes
Medical Affairs & PV guidelines
Proven track record in risk assessment, audits, inspections, and compliance management.
Collaborative leadership style; ability to work across teams and functions.
Strong communication skills (verbal & written).
High level of proactiveness, attention to detail, and problem-solving ability.
Proficiency in MS Office suite.
Additional Information
Must be a U.S. citizen, lawful permanent resident, or otherwise authorized to work in the U.S. without visa sponsorship (now or in the future).
Compensation & Benefits
Competitive base salary (based on experience, role, and location).
Annual discretionary bonus eligibility.
Comprehensive healthcare coverage, retirement savings plan, and leave benefits.
Further details on total rewards will be shared during the hiring process.
Our Work Culture
At Dr. Reddy’s, people are at the core of everything we do. We foster a culture of empathy, innovation, teamwork, and shared success. Guided by our purpose “Good Health Can’t Wait”, we see healthcare not just as science, but as an opportunity to help patients live healthier, fuller lives.
Equal Opportunity Employer
We are an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
🔗 Learn more & apply: Dr. Reddy’s Careers
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