Medical Safety Assessment Physician

Location
08648, Lawrence Township
Posted
Dec 17, 2020
Required Education
Doctorate/PHD/MD
Position Type
Contract

Our client, a leading global pharmaceutical company is seeking a Medical Assessment Safety Physician on a long term contracting basis

Responsibilities:

  • 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