Head Pharmacovigilance - North America

At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.

Diversity, Equity & Inclusion
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.

Job Description

We are seeking an exceptional leader to head our Pharmacovigilance function for North America. Incumbent will also provide oversight on medical affairs and medical information services and support in providing strategic inputs to cross functional teams as well as initiate, improve and monitor the execution of existing systems.

The role will be based in Princeton, NJ and report to Global Head of Pharmacovigilance.

Roles & Responsibilities

• Maintain and identify pharmacovigilance processes and procedures to be documented and set up. Ensure that the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements.
• Continuously monitor NAG pharmacovigilance regulations and notify Global Pharmacovigilance (GPV) of any changes.
• Oversee compliance with NAG pharmacovigilance regulations (e.g. intake of adverse events, processing, timeliness of submission and quality of expedited ICSRs, PADERs, and timely responses to Regulatory Authority requests).
• Lead the interaction between the USFDA and Health Canada for all aspects of pharmacovigilance and product safety.
• Ensure GPV is notified of changes to the product portfolio, including new approvals, and sharing the Prescribing Information (PI), both new and revised.
• Ensure GPV is promptly notified of any significant regional safety concerns.
• Be aware of any post-authorization safety studies requested by the Regulatory Authority for the region.
• Anchor drug safety regulatory inspection in US (FDA) and participate in audits; provide support in external audits. Drive successful PV audits to achieve no critical findings and provide post-inspection report with corrective action plan.
• Review current reporting period against historical data to evaluate risks, identify potential risk areas, and develop proposals for regulatory agencies. Manage REMS program, budget and ensure regulatory sign‑off with corrective actions when necessary.
• Support development and execution of North America Medical Affairs plans and Dr. Reddy's Canada Medical Affairs plans in alignment with clinical practice and corporate objectives.
• Provide oversight of medical information services for North America and ensure seamless communication with Pharmacovigilance service providers.
• Engage cross-functionally to maximize reporting relationships and support scientific congress attendance with planning and post-meeting reporting.
• Ensure oversight of any local pharmacovigilance service providers, if applicable.
• Provide support for regional audits and inspections as required.
• Oversee training of PV and non-PV personnel in the region.
• Drive communication and collaboration on PV matters with individual countries in the region through leadership meetings, ensuring access and input to the global PV system and escalation of regional/local safety issues.
• Oversee pharmacovigilance trainings, QMS and compliance activities for monthly compliance meetings and reporting. Develop and implement regional/local PV procedures and training aligned with global documents.
• Perform any other pharmacovigilance activities as delegated by the Global Head of Pharmacovigilance.

Incumbent should be willing to work in person from our Princeton, NJ office.

Qualifications

Educational qualification: Medical degree is required.

Minimum work experience: 10+ years in PV in the pharmaceutical industry.

Preferred experience working on post-marketed generic drugs.

Skills & attributes:

• Preferred understanding of North American pre- and post-marketing regulatory requirements for Medical Affairs and Medical Information activities.
• Knowledge of FDA and Health Canada: Drug Discovery and Development Processes; Clinical Development Tools and Processes; Medical Affairs Guidelines; Regulatory Guidelines; Pharmacovigilance Guidelines; Domains across the pharma value chain.
• Collaborative team player with ability to work across teams and functions.
• Proactiveness with attention to detail.
• Excellent communication skills (verbal & written); MS Office suite.
• Demonstrated ability to manage multiple projects, solve problems, deliver on commitments, and work with multidisciplinary teams.

Additional Information

Must be a U.S. citizen or lawful permanent resident of the U.S. or otherwise authorized to work in the U.S. without visa transfer or sponsorship, now or in the future.

Dr. Reddy's Laboratories offers a competitive total rewards package including base salary determined by role, experience, skill set and location. Employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Details about total compensation and benefits will be provided during the hiring process.

Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We foster a culture of empathy and dynamism, with people at the core of our journey. We believe that diverse skills bound together by a common purpose and values can create meaningful impact.

Equal Opportunity Employer

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

For more details, please visit our career website at

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