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 product. Leaders 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 Officer (GSO) for Marketed Products serves 2 roles: 1) safety expert of the assigned marketed product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned marketed products.
The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global Safety Scientists.
Applicable tasks may vary by product(s) assigned.
Product safety profile, benefit-risk evaluation, and risk communication:
Signal detection, evaluation, and management:
Risk management and minimization:
Periodic (aggregate) safety reporting:
Safety Governance Leadership:
Amgen commercialization process:
MBBS or equivalent degree from an accredited medical school
12 years of directly related experience OR MD of a foreign medical school
Product safety in the bio/pharmaceutical industry/CRO or regulatory agency
Previous management and/or mentoring experience
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
