Head Pharmacovigilance – North America
Location: Princeton, New Jersey, USA (Onsite)
Department: Pharmacovigilance
Company: Dr. Reddy’s Laboratories
Reporting To: Global Head of Pharmacovigilance
About Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories is a global pharmaceutical organization driven by its purpose, “Good Health Can’t Wait.” The company is committed to delivering affordable and innovative medicines while maintaining the highest standards of patient safety, regulatory compliance, and scientific integrity. With a strong emphasis on diversity, equity, and inclusion, Dr. Reddy’s fosters a collaborative and performance-oriented work environment.
Position Overview
Dr. Reddy’s Laboratories is seeking an experienced and strategic leader to head the Pharmacovigilance (PV) function for North America. This senior leadership role will oversee regional drug safety operations, medical affairs coordination, and medical information services while ensuring full compliance with U.S. and Canadian pharmacovigilance regulations.
The incumbent will drive pharmacovigilance quality systems, regulatory inspections, audit readiness, and cross-functional collaboration across commercial, regulatory, and medical teams. This role requires deep expertise in North American regulatory frameworks and strong leadership in building compliant, inspection-ready pharmacovigilance systems.
Key Responsibilities
Pharmacovigilance Leadership & Regulatory Compliance
Establish, maintain, and continuously improve regional pharmacovigilance processes and Quality Management Systems (QMS) in compliance with U.S. FDA and Health Canada requirements
Monitor evolving North American pharmacovigilance regulations and communicate regulatory changes to Global Pharmacovigilance (GPV)
Ensure timely intake, processing, submission, and quality control of ICSRs, PADERs, and expedited reports
Lead regulatory interactions with U.S. FDA and Health Canada on drug safety matters
Ensure alignment between regional product portfolio updates and global safety systems
Inspection, Audit & Risk Management
Serve as the regional pharmacovigilance lead during FDA inspections and regulatory audits
Drive successful PV audits with zero critical findings and oversee corrective and preventive action (CAPA) plans
Conduct periodic safety data review to identify trends, risk signals, and product risk-benefit assessments
Manage REMS programs, associated budgets, and regulatory approvals
Oversee post-authorization safety studies requested by regulatory authorities
Medical Affairs & Medical Information Oversight
Provide strategic input to North America Medical Affairs plans aligned with commercial brand strategy
Oversee regional medical information services and coordinate with pharmacovigilance service providers
Support scientific congress planning, competitive intelligence reporting, and cross-functional initiatives
Cross-Functional & Regional Governance
Lead pharmacovigilance training programs for PV and non-PV personnel
Ensure oversight of regional PV service providers
Conduct regular leadership meetings to address safety governance across North America
Escalate regional safety concerns into the global PV system as appropriate
Develop and implement regional PV SOPs and training modules aligned with global standards
Educational Qualification
Advanced scientific degree required: MD, Pharm.D., PhD, or equivalent
Experience Required
Minimum 10+ years of progressive pharmacovigilance experience within the pharmaceutical industry
Demonstrated leadership experience managing regional or global PV operations
Prior direct interaction with U.S. FDA and/or Health Canada regulatory authorities
Experience leading regulatory inspections and pharmacovigilance audits
Required Skills & Competencies
In-depth knowledge of North American pre- and post-marketing regulatory frameworks
Strong understanding of FDA and Health Canada pharmacovigilance guidelines
Expertise across the pharmaceutical value chain including clinical development, medical affairs, and regulatory affairs
Proven ability to manage complex projects and multidisciplinary teams
Strong analytical skills for safety signal evaluation and risk-benefit analysis
Excellent written and verbal communication skills
Proficiency in Microsoft Office Suite
High attention to detail and proactive leadership approach
Work Authorization
Candidates must be U.S. citizens, lawful permanent residents, or otherwise authorized to work in the United States without visa sponsorship now or in the future.
Compensation & Benefits
Dr. Reddy’s Laboratories offers a competitive total rewards package, including base salary aligned with experience and market benchmarks, annual discretionary bonus eligibility, comprehensive health benefits, retirement savings plans, and paid leave programs. Detailed compensation information will be shared during the hiring process.
Work Culture
At Dr. Reddy’s, employees are united by a shared mission to expand access to safe and effective healthcare solutions. The organization promotes innovation, accountability, and cross-functional collaboration while maintaining the highest standards of compliance and patient safety.
Equal Employment Opportunity
Dr. Reddy’s Laboratories is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, age, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
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