Global Safety Senior Medical Scientist - Inflammation

Global Safety Senior Medical Scientist - Inflammation

This role provides content and technical support to the GST in the evaluation of safety data and production of GST deliverables under the supervision of the Global Safety Officer (GSO). Due to significant experience in the role from a scientific and technical perspective this role requires increased independence and leadership with less direct supervision of content driven activities by the GSO. The incumbent must be able to serve as GSO delegate for internal and potentially external Amgen meetings (Data Monitoring Committee, Ad-com representation).

Key Activities:

Support Global Safety Officer (GSO) in the clinical interpretation of safety signals and evaluations of aggregate safety data including analytical strategy and search methodology

Responsible for producing presentations for Product Safety Review Meetings (PSRM) and other scientific presentations under the guidance of the GSO

Contribute content support to the development of strategy and creation of product risk management plans, safety updates, safety assessment reports, and other GST deliverables

Safety content and expertise in support of Investigator Meetings, Data Monitoring Committees and DRTs, responses to regulatory authorities, safety sections of clinical trial documents

Basic Qualifications
MD or DO degree from an accredited medical school

Completion of an accredited medical or surgical residency
OR
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

Preferred Qualifications
Current registered medical license

Board certified or Board eligible

Accredited fellowship or clinical experience

Clinical experience, including training

Drug safety experience