Pharmacovigilance Specialist (Hybrid)

McKesson; Cork; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

McKesson is seeking a Drug Safety & Pharmacovigilance Specialist based in Cork, Ireland to lead day-to-day safety activities for our private label portfolio. You will log, assess, investigate, and report adverse events, maintain safety data exchange with suppliers, and ensure FDA/ICH compliance within a growing Regulatory Affairs team.

The role requires hands-on pharmacovigilance experience, attention to detail, and the ability to manage multiple safety activities in a fast-paced environment.

Qualifications

• Degree or equivalent with 4+ years in pharmacovigilance or regulatory affairs.
• Hands-on pharmacovigilance covering adverse event handling and safety reporting.
• Experience with FDA, ICH guidelines, and QMS.

Responsibilities

• Perform post-marketing safety surveillance and log, assess, investigate and close adverse events.
• Complete monthly reconciliation of complaints and adverse events and prepare metrics.
• Review and approve safety reports including expedited reports and signal trending.
• Manage lifecycle of supplier safety data exchange agreements.
• Prepare annual pharmacovigilance audit schedule and perform audits.
• Support product field alerts and safety queries under SPAs.
• Analyze and trend safety data and escalate issues.
• Support new product launch process for US private label products.
• Adapt to additional duties to meet company goals.

Skills

Regulatory Affairs

Pharmacovigilance

Adverse Event Handling

FDA Regulations

Quality Management

Regulatory Submissions

Detail-oriented

Multi-tasking

Risk Assessments

Education

Bachelor's degree in Life Sciences

Tools

MasterControl

Argus

Job description

McKesson is seeking a Drug Safety & Pharmacovigilance Specialist based in Cork, Ireland to lead day-to-day safety activities for our private label portfolio. You will log, assess, investigate, and report adverse events, maintain safety data exchange with suppliers, and ensure FDA/ICH compliance within a growing Regulatory Affairs team.

The role requires hands-on pharmacovigilance experience, attention to detail, and the ability to manage multiple safety activities in a fast-paced environment.