Global Safety Associate Medical Director

• 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

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