Pharmacovigilance Physician

Pharmacovigilance Physician Overview

• The Pharmacovigilance Physician will provide medical oversight and safety expertise across clinical and post-marketing programs.
• This role supports benefit-risk assessments, medical review of safety data, and regulatory safety deliverables.
• Collaborate with cross-functional teams to ensure compliance with global pharmacovigilance requirements.
• Engage in safety surveillance, signal detection, and evaluation activities to ensure patient safety.
• Provide medical input for regulatory submissions and responses to authority inquiries.
• This is a remote, contract-based position with potential for extension.
• Opportunity to contribute to safety strategy discussions and governance processes.

Pharmacovigilance Physician Key Responsibilities & Duties

• Perform medical reviews of individual case safety reports, including serious and medically significant events.
• Assess adverse events for causality, expectedness, and clinical relevance.
• Review aggregate safety data from diverse sources to identify emerging safety issues.
• Author or medically review safety documents such as DSURs, PSURs, and RMPs.
• Collaborate with Clinical Development to integrate safety considerations into study designs.
• Support Safety Operations teams with case processing guidance and medical queries.
• Ensure compliance with global pharmacovigilance regulations and guidelines.
• Participate in safety audits, inspections, and governance processes as needed.

Pharmacovigilance Physician Job Requirements

• Doctor of Medicine (MD) or equivalent medical degree is required.
• Minimum of 3-5 years of experience in pharmacovigilance, drug safety, or clinical development.
• Strong understanding of global PV regulations, ICH guidelines, and clinical trial processes.
• Experience with safety databases such as Argus, ARISg, or Veeva Safety is preferred.
• Ability to interpret complex clinical data and provide clear medical rationale.
• Excellent written and verbal communication skills are essential.
• Experience with both clinical trial and post-marketing safety is advantageous.
• Prior work within a biopharma company, CRO, or regulatory agency is preferred.