MSI Pharma are working with a growing oncology focused bio tech to hire 2 freelance safety physicians - one US based & one European based.

We are looking for candidates with the following profile;

MD/MBBS with clinical experience
8+ years global safety experience in a clinical development


The role;

• Operates as safety expert for assigned in development and keeps on top of the safety profile of the products in the same class as company products
• Works on aggregate reports required for routine signal detection activities for products in development
• Performs safety signal detection and evaluation using scientific judgement from data derived from multiple sources including clinical and post marketing safety data, public ADR databases, and literature
• Works with Safety Operations and Bio-metrics to ensure that outputs of safety data from both safety and clinical trial databases meet the need for prep of aggregate safety reports including PADER, DSUR, PSUR/PBRER, and other required aggregate safety analyses required by regulatory authorities and works with Safety Scientist(s)/Medical Director(s) in creating the required documents
• Works with Product Safety Leads to facilitate and prepare materials for Product Safety Committees and Safety Assessment Committee in line with Safety Governance principles
• Provides pharmacovigilance data analysis and writing expertise as required for preparation of a range of global regulatory reports including PADER, RMP, DSUR, PSUR/PBRER, and Signal Detection Assessment Report
• Works with Safety Scientist/Medical Director in the creation and review of safety input for IB, informed consent forms, and the response to ad hoc safety queries

Keywords

Clinical development, Pharmacovigilance, Patient Safety, PV, Safety Physician, Oncology