Job Purpose? The Drug Safety & Pharmacovigilance Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned products throughout lifecycle.

Responsibility?

• Responsible for implementing risk management strategies for assigned product.
• Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses.
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents.
• Effectively collaborate with drug safety and cross-functional teams for safety assessment (e.g. review of AEs; safety reports; trial protocols; clinical study reports), ongoing surveillance, and related communication around assigned products.
• Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management.

Requirements

• MD required.
• Minimum requirement: 10+ years' experience in in drug safety/pharmacovigilance physician in clinical development in oncology
• Oncology experience and clinical development experience strongly preferred
• Experience with global PV regulatory environment (regulations, initiatives, standards, GVP)
• Work collaboratively and lead cross-functional teams

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.