Global Safety Associate Medical Director

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