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26 Oct 2020

Temporary Medical Assessment Safety Physician ( 20-16673)

Axelon Services Corporation – Posted by iris.chen@axelon.com Lawrence Township, New Jersey, United States

Job Description

“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: Title: Medical Assessment Safety Physician

Job 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 Client 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

How to Apply

Please send your updated resume to iris.chen@axelon.com

Job Types: Temporary.

Job expires in 60 days.

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