Drug Safety Physician

Company: Sunrise Systems
Location: Trenton
Posted on: January 11, 2021

Job Description:

Sunrise System Inc. is currently looking for Drug Safety Physician in Lawrence Township, NJ with one of our top client.Job Title: Drug Safety PhysicianLocation: Lawrence Township, NJ 08648Duration: 6+ monthsPosition Type: Hourly contract Position (W2 only)Title: Drug Safety PhysicianJob Description:--- 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 BMS 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 managementContactSatya - Delivery ManagerDirect: (732) 272 0262 -Email: satya@sunrisesys.com

Keywords: Sunrise Systems, Trenton , Drug Safety Physician, Healthcare , Trenton, New Jersey