Job details
Job type full-time
Full job description
Career category
Safety
Job description
Amgen is seeking a global safety medical director at its main headquarters in thousand oaks, california to join the global patient safety (gps) organization reporting to the executive medical director global safetyOther locations may be considered.
The global safety therapeutic areas serve as the safety experts for all amgen products globally and are accountable for the safety strategy and major safety deliverables for each amgen productLeaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in global patient safety and support gps in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.
The global safety medical director serves 2 roles:
Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities and is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.
Leads the safety analysis team (sat), global safety team (gst) and is a core member of the executive safety committee (esc)Serves as a member of the evidence generation team and other relevant cross functional teams and will be assigned as delegate for the therapeutic area head (tah) and has management of global safety physicians.
Key activities
Validate safety signals and lead safety signal assessments
Develop and maintain core safety information (core data sheet, core risks in informed consent forms, etc.)
Prepare/review core and regional risk management plans including additional risk minimization measures
Prepare/review safety sections of periodic aggregate reports
Provide safety input to protocols, statistical analysis plans, and clinical study reports
Prepare/review safety sections of new drug applications and other regulatory filings
Serve as safety expert on evidence generation team for assigned products
Inspection readiness
Travel: domestic and international travel up to 10% may be essential
Basic qualifications
Md or equivalent degree from an accredited medical school with 2 years of industry pharmacovigilance (pv) experience
And
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
Product safety in the bio/pharmaceutical industry or regulatory agency
Previous management and/or mentoring experience
Board certification or equivalent training
Expertise in either oncology, hematology or inflammation
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the san francisco fair chance ordinance.
