Global Safety Associate Medical Director

Career Category Safety Job Description 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 .   Key Activities   Applicable tasks may vary by product(s) assigned.       Product safety profile, benefit-risk evaluation, and risk communication :   Accountable for the Development and maintenance of core reference safety information ( e.g   Core safety information portions of Core Data Sheet [CDS])   Identify   relevant data and conduct benefit-risk evaluation   Participate in product label process     Clinical trial safety :   Develop a strategy as needed for preparing and updating safety related portions of the Informed Consent Form and other study related documents for trials conducted post marketing.   Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees   Perform signal detection   activities   for developmental products under the direction of the GSO leading the product in development.      Signal detection, evaluation, and management :   Develop signal detection strategy   Evaluate safety signal detection findings ,   validate   signals   and   determine   a need and develop a strategy for   further analysis   Decide on need for further actions on safety issues and lead cross-functional discussion   Documents work as   required   in the safety information management system   Prepares and presents recommendations on safety issues to the Global Safety Team and escalates as   appropriate to   the executive level cross-functional decision-making body   Approves the safety assessment report   M ay search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection   Documents work as   required   in the safety information management system     Risk management and minimization :   Ensure   timely   preparation, content, and quality of new or updated risk management plan (RMP) document   Develop a strategy for safety risk minimization measures globally (including US REMS if applicable)   Develop materials for   additional   risk minimization measures as applicable to role     Periodic (aggregate) safety reporting :   Ensure   timely   preparation and quality of periodic reports (e.g., PSUR/PBRER)   Review and approve periodic safety reports     Safety Governance Leadership :   Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g.   Facilitates , Chairs, Presents)     Amgen commercialization process :   Represents   and contributes on behalf of Global Patient Safety on Evidence Generation Teams     Inspection Readiness :   Undertake activities delegated by the QPPV as detailed in the PV System Master File and   maintain   a state of inspection readiness   Be representative and point of contact for Health