Drug Safety and Post Marketing Surveillance Manager

Lead, coach, and develop a team of drug safety and pharmacovigilance specialists, supporting their growth through individual development plans and a culture of learning.

Own the post-market surveillance program, ensuring product complaints, adverse events, and medical queries are critically evaluated and assessed for potential safety risks and market action.

Prepare and submit safety reports to the FDA on time, including field alert reports and reports of illegitimate product, and interpret regulations to assess their impact on the business.

Lead the private label product recall process, working directly with the FDA and suppliers to resolve recalls promptly and without undue delay.

Manage the lifecycle of supplier safety data exchange agreements and provide oversight of the third-party medical information service provider, including budget planning and cost management.

Operate within the Quality Management System across all regulatory activities, support the pharmacovigilance audit plan, and provide technical guidance to teams and senior leadership.

Partner cross-functionally to support new private label product launches, providing guidance on risk identification and a risk-based approach to compliance.

Other duties may be assigned as needed to meet company goals.

Minimum Requirement

Degree or equivalent experience. Typically requires 6+ years of professional experience and 0-2 years of supervisory experience

Critical Skills/Experience

4+ years of Regulatory Affairs experience within a multinational pharmaceutical organisation.

4+ years of hands-on pharmacovigilance and/or drug safety experience, such as adverse event assessment, safety signal evaluation, or case reporting.

2+ years operating within a Quality Management System, including quality processes such as deviations and corrective and preventive actions (CAPAs).

1+ years of people leadership or supervisory experience.

Working knowledge of FDA regulations, ICH guidelines, and other applicable U.S. and international regulatory requirements.

Experience with regulatory submissions and strong technical writing skills.

Strong project management, problem-solving, and decision-making skills, with the ability to prioritize and manage multiple assignments.

Preferred Skills/Experience

Experience in the generics or private label pharmaceutical market.

Degree or higher in Chemistry, Microbiology, or another scientific discipline, with typically 6+ years of relevant regulated pharmaceutical experience.

Hands-on experience with quality and safety systems such as MasterControl and Argus, and experience supporting product recalls.

Interest in or exposure to applying artificial intelligence (AI) tools to drug safety and regulatory workflows.

Work Environment/Physical Demands:

Hybrid working model with the ability to work from home and in the general office environment. International travel may be required occasionally to meet business needs.

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