Global Safety Associate Medical Director

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 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   M ay 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   P artnerships 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   A ccountable 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   Knowledge and Skills   Processes and regulations for pharmacovigilance and risk management   Advanced understanding of interfaces across various pharmacovigilance and risk management processes   Drug development and lifecycle management   Safety data capture in clinical development and post-market settings   Safety database structure and conventions   MedDRA and other dictionaries used in pharmacovigilance   Methods of qualitative and quantitative safety data analysis   Product and disease state knowledge   General medicine, epidemiology, physiology, and pharmacology   Internal organizational and governance structure   Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product   labelling   Pharmacovigilance skills   Signal detection and evaluation   Aggregate data analysis   Good clinical and scientific judgment   Application of medical concepts and terminology   Document writing and source document review   Data interpretation and synthesis   Basic skills in application of statistical and epidemiological methods to pharmacovigilance   Ability to convey complex, scientific data in an understandable way   Ability to   analyze   and interpret complex safety data   Advanced skills in application of statistical and epidemiological methods to pharmacovigilance   O ther skills :   Strategic thinking   Effective team and strategic leadership, influencing, and negotiation in a cross-functional, matrix environment   Big picture perspective and context analysis   People and team management   Conflict management   Organization, prioritization, and planning of work   Project management   Critical scientific assessment and problem solving   Oral presentation skills   Written communications and medical/scientific writing   Computer skills (e.g., MS Office Suite and safety systems)     C ompetencies     KNOWLEDGE :   Serves as a technical authority within the organization   Develops advanced/leading-edge technologies and/or concepts that have global reach and applicability   P ROBLEM SOLVING :   Applies global thought leadership   Shapes long-term strategic direction and reputation of Amgen   Provides   authoritative advice to top management   Leads organizational invention at a global level   AUTONOMY :   Models   organizational standards for innovation   Directs projects of critical importance to Amgen   CONTRIBUTION :   Serves as expert advisor to top management and is a sponsor for large-scale projects   Ensures products and services are aligned with current and future needs and expectations including the following:   Business needs   Medical field   Res