Instagram
youtube
Facebook

Head Pharmacovigilance & Medical Affairs

10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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