**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 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 + May 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 Authority Inspection and Internal Process Audits within the remit of role and responsibility + Partnerships and integration activities + Participate in safety agreement development and review process + Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement + Perform safety due diligence in preparation for partnerships, etc. + Participate in integration activities **Other Amgen processes:** + Interact with external stakeholders (e.g., advisory boards) on safety-related topics + Prepare for and participate in regulatory agency advisory committees + Provide safety input to support legal needs + Managerial and supervisory responsibilities + Oversees day to day activities of the Global Safety Physician if applicable + Ensure staff are compliant with Amgen corporate and departmental training and SOP review + Provide training, coaching, mentoring, and development of staff + Assist in the recruitment of talented GPS and AMGEN staff + Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes + Development plans for staff created annually and reviewed quarterly **Education & Experience (Preferred)** + Medical Degree (MBBS or MD) required from an accredited medical school with atleast 8 years of relevant experience . + Product safety in the bio/pharmaceutical industry/CRO or regulatory agency + Previous management and/or mentoring experience + Clinical/medical research experience