Drug Safety & Pharmacovigilance Specialist
About the Role The Drug Safety & Pharmacovigilance Specialist performs the day-to-day drug safety and post-market surveillance activities that keep McKesson's private label pharmaceutical products safe, compliant, and continuously available to patients. Based in Cork and reporting to the Drug Safety and Post Marketing Surveillance Manager, you will help ensure compliance with U.S. Food and Drug Administration (FDA) regulations by logging, assessing, investigating, and reporting safety events across our portfolio. This role sits within a growing Regulatory Affairs team and partners closely with Quality, internal departments, and external suppliers to manage risk and minimize supply interruptions. The ideal candidate brings hands-on pharmacovigilance expertise, strong attention to detail, and the ability to manage multiple safety activities in a fast-paced, evolving environment.
What You'll Do
Perform post-marketing safety surveillance activities, ensuring all complaints and adverse events are logged, assessed for regulatory reporting requirements, investigated, and closed in a timely manner.
Complete monthly reconciliation of complaints and adverse events and prepare monthly metrics and reports for the Quality department and management.
Review and approve safety reports, including expedited reports, periodic adverse drug event reports, and signal trending reports.
Manage the lifecycle of supplier safety data exchange agreements and interface with key pharmacovigilance service providers.
Prepare the annual pharmacovigilance audit schedule and perform audits of generic drug (ANDA) applicants and pharmacovigilance service providers.
Support product field alert and other safety reporting, and support medical communications queries in line with applicable safety data exchange agreements.
Analyze and trend safety data, escalate product, supplier, or system issues, and track them through to resolution.
Support the new product launch process for McKesson U.S. private label products and maintain a current understanding of emerging pharmaceutical regulations.
Other duties may be assigned as needed to meet company goals.
Minimum Requirement
Degree or equivalent and typically requires 4+ years of relevant experience.
Critical Skills/Experience
3+ years of Regulatory Affairs experience within a multinational pharmaceutical organisation.
Hands-on pharmacovigilance experience covering day-to-day safety activities such as adverse event handling, case assessment, and safety reporting.
Experience recording and handling customer complaints, adverse events, and queries, including complaint-related risk assessments.
Working knowledge of FDA regulations, ICH guidelines, and other applicable U.S. and international regulatory requirements.
Experience operating within a Quality Management System.
Technical writing skills, including experience with regulatory submissions.
Strong attention to detail, problem-solving, and decision-making skills, with the ability to prioritize and manage multiple activities.
Preferred Skills/Experience
European pharmacovigilance/regulatory experience (a strong plus alongside U.S. FDA knowledge).
Experience in the generics or private label market, or supporting brand-new products entering the market.
Familiarity with quality and safety systems such as MasterControl and Argus, and experience with pharmacovigilance audits and Field Alert Reports.
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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