Description

**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