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.
Job Summary
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 developmen

📌 Global Safety Associate Medical Director (Hyderabad)
🏢 AMGEN
📍 Hyderabad