Drug Safety and Post Marketing Surveillance Manager
At a glance
Mid-level General Marketing role at McKesson. 2 Locations · full-time.
Pay not stated General Marketing salary
Growth Roles summary, based on the employer's posting.
What you'll do
- Lead and develop drug safety and pharmacovigilance specialists through coaching and individual growth plans
- Run post-market oversight for complaints, adverse events, medical queries, safety signals, and possible market actions
- File FDA safety submissions, including field alerts and illegitimate-product reports, while interpreting regulatory impact
- Direct private-label recalls with FDA and suppliers, and manage supplier safety agreements and medical-information providers
- Apply the Quality Management System to regulatory work, audits, launches, risk assessment, and compliance guidance
What you bring
- A degree or equivalent experience, with typically at least six years in professional work
- At least four years in Regulatory Affairs within a multinational pharmaceutical organization
- At least four years handling pharmacovigilance or drug safety work such as signal review or case reporting
- At least two years using a Quality Management System, including deviations and CAPAs
- At least one year supervising people, plus working knowledge of FDA, ICH, and related requirements
Who this fits
You’ll suit a hands-on regulatory and pharmacovigilance manager who can lead a specialist team and make safety decisions. The role is based in Cork with hybrid work between home and the office, and occasional international travel may be needed.
From the employer
About the Role
The Drug Safety and Post Marketing Surveillance Manager leads the safety and post-market oversight of McKesson's private label pharmaceutical products, ensuring they remain safe, compliant, and continuously available to patients. In this newly created role, based in Cork and reporting to the Director of Regulatory Affairs, you will lead a team of drug safety and pharmacovigilance specialists while owning the post-market surveillance program from end to end. This role partners closely with Quality, Regulatory, suppliers, and external service providers to evaluate safety signals, manage recalls, and ensure compliance with U.S. Food and Drug Administration (FDA) regulations. The ideal candidate blends hands-on pharmacovigilance and quality expertise with the leadership skills to coach a growing team in a fast-paced, evolving environment.
What You'll Do
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.
McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:
McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
McKesson job postings are posted on our career site: careers.mckesson.com.
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