Drug Safety & Pharmacovigilance Specialist

About the role

The Drug Safety & Pharmacovigilance Specialist ensures McKesson's private‑label pharmaceutical products remain safe, compliant, and continuously available to patients. Based in Cork and reporting to the Drug Safety and Post‑Marketing Surveillance Manager, the role supports FDA compliance through diligent logging, assessment, investigation, and reporting of safety events.

Key responsibilities

• Perform post‑marketing safety surveillance, logging and assessing complaints and adverse events for regulatory reporting.
• Complete monthly reconciliation of complaints and adverse events and generate metrics for Quality and management.
• Review and approve safety reports, including expedited, periodic, and signal‑trending reports.
• Manage supplier safety data exchange agreements and liaise with pharmacovigilance service providers.
• Prepare the annual pharmacovigilance audit schedule and audit generic drug (ANDA) applicants and service providers.
• Support product field alerts, safety reporting, and medical communications queries.
• Analyze and trend safety data, escalating and tracking product, supplier, or system issues to resolution.
• Assist with new product launches and stay current on emerging pharmaceutical regulations.

Required profile

• Degree or equivalent with typically 4+ years of relevant experience.
• 3+ years of Regulatory Affairs experience in a multinational pharmaceutical organization.
• Hands‑on pharmacovigilance experience covering adverse event handling, case assessment, and safety reporting.
• Experience recording and handling customer complaints, adverse events, and risk assessments.
• Working knowledge of FDA regulations, ICH guidelines, and other applicable U.S. and international requirements.
• Experience operating within a Quality Management System.

Required skills

• Pharmacovigilance
• FDA regulations
• ICH guidelines
• Quality Management System
• Technical writing for regulatory submissions