ED/SD, Global Drug Safety & Pharmacovigilance Physician

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.