This is an opportunity for a Medical Director to serve in a Global Safety Officer GSO role within the Oncology Therapeutic area in Amgen Global Safety.
The role is located at Amgen's headquarters in Thousand Oaks, California.
The Global Safety Medical Director (also known as the Global Safety Officer (GSO)) leads by establishing the direction and priorities of the Global Safety Team (GST) and is accountable for all product safety related GST decisions for assigned products and is the key interface between the GST, Therapeutic Area Head (TAH), Amgen Global Safety Senior Management, and other Amgen functional areas. The GSO, supported by the Global Safety Project Manager, is responsible for the timely communication of safety recommendations and/or actions from the GST to internal and external stakeholders. This role leads single projects which can be of moderate or high complexity / scope or multiple projects of lower complexity closely collaborating with the Therapeutic Area Head.
Key Activities:
Accountable for identification, assessment, and communication of potential safety signals as leader of GST pharmacovigilance activities
GST representative on the PST (commercialization) accountable for GST PST deliverables
Lead response to regulatory safety queries
Lead development of strategy and creation of product risk management plans including maintenance and updates
Accountable for Global Safety Strategic Plan (GSSP)
Safety representative for assigned products at meetings with Regulatory authorities, data safety monitoring committees, advisory boards
Participate in planning, review and sign off of clinical trial safety documents for content including: o Clinical Summary of Safety (CSS) o 120 Day safety update o Protocol safety sections o CSRs o ICFs o Study safety monitoring plans o Investigator Brochures
Basic Qualifications MD or DO degree from an accredited medical school
2+ years of safety experience
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 Drug safety, biotech/pharmaceutical or regulatory agency experience
Board Certification by an accredited medical or surgical board e.g. ABIM, ABMS, EUMS
