Medical Safety Assessment Physician
Our client, a leading global pharmaceutical company is seeking a Medical Assessment Safety Physician on a long term contracting basis
- Oversee, Prepare, and/or Review aggregate safety review documents (eg, DSUR, PBRER) and safety sections of relevant clinical trial documents (eg, protocols, clinical study report [CSR], investigator brochure [IB], informed consent form [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]).
- Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries.
- Lead the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.
- Lead safety activities and benefit-risk strategies for assigned compound(s)/ program and chair the product SMT(s) as required.
- Assist the team and senior management in all forms of issue management and crisis management