Senior Drug Safety & Post-Market Lead

McKesson; Cork; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

McKesson is seeking a Drug Safety and Post Marketing Surveillance Manager in Cork. You will lead a multidisciplinary team to oversee safety, post-market activities, and regulatory submissions, partnering with QA, Regulatory, and suppliers to ensure compliant operations.

The role requires 6+ years in regulatory affairs and pharmacovigilance, with prior leadership experience and strong writing skills to support FDA reports and recalls. Hybrid work with occasional international travel is expected.

Qualifications

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

Responsibilities

• 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.

Skills

Regulatory Affairs

Pharmacovigilance

Quality Management

People Leadership

FDA Regulations

Regulatory Submissions

Project Management

Technical Writing

Education

Bachelor's Degree

Tools

MasterControl

Argus

Job description

McKesson is seeking a Drug Safety and Post Marketing Surveillance Manager in Cork. You will lead a multidisciplinary team to oversee safety, post-market activities, and regulatory submissions, partnering with QA, Regulatory, and suppliers to ensure compliant operations.

The role requires 6+ years in regulatory affairs and pharmacovigilance, with prior leadership experience and strong writing skills to support FDA reports and recalls. Hybrid work with occasional international travel is expected.