Sr Medical Dir Global Safety

Career Category Safety

Job Description

Group Purpose 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 Senior Global Safety Officer (GSO): serves as the safety expert of the assigned product(s) and provides oversight of other GSOs and Global Safety Physicians (GSP), setting the strategy, direction, and priorities of pharmacovigilance activities and supervising and contributing to their execution. The Senior GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products and oversight for direct reports’ accountable products. The Senior GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC) for assigned products and oversees direct reports leading these activities. The GSO also is a member of the Evidence Generation Team (EGT) for assigned products. The GSO will be assigned as delegate for the TA Head as needed and has management of Global Safety Physicians and Global Safety Officers. Key Activities Applicable tasks may vary by product(s) assigned. Medically relevant activities requiring input can be delegated to the Global Safety Physician while remaining accountable for the activities (e.g. validate a signal). Senior GSO has direct responsibilities in these activities and oversight of direct reports leading these activities. Accountable for providing strategic oversight and direction for all major regulatory safety submissions and responses or strategic deliverables including but not exclusive to Safety sections of NDA submissions, clinical overview, RMPs, PSURs, PBRERs, DSURs, DILs. Leads the safety strategy and Benefit/Risk Management Process for assigned portfolio and provides ongoing monitoring of safety profiles for Amgen products worldwide as well as oversight of these responsibilities for direct reports. Chairs or participates in safety governance meetings per Standard Operating Procedures and Manuals. At the GST meeting, can be delegated by TA Head to endorse decisions for Risk Level 3 risk mitigation and communication actions and is a core team member of the ESC. Serves as a sponsor/oversight and/or SME for functional and/or cross functional projects for process improvement as needed. Product safety profile, benefit-risk evaluation, and risk communication Accountable for the Development and maintenance of core reference safety information (e.g., Development Core Safety Information [DCSI], 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 Represent GPS on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents and charters including aggregate review of safety data reports Develop a strategy as needed for updating safety-related portions of Investigator’s Brochure and Informed Consent Form Participate in activities related to Data Monitoring Committees (DMCs) and internal data review teams (DRTs) Analyze safety data from clinical studies and contribute to core safety messages and conclusions in clinical study reports and review all sections of CSR as safety delegate Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees Signal detection, evaluation, and management Develop signal detection strategy Evaluate safety signal detection findings and validate signals iteratively as needed and document in appropriate management systems. Prepares and presents recommendations on safety issues with medical and indication context including safety data and literature with relevant indication and competitor information, to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body Approves the safety assessment report 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, DSUR) Review and approve periodic safety reports New drug applications and other regulatory filings Author messaging, Reviews and approves filing documents relevant to drug safety Develop a strategy for and lead preparation of response to regulatory agency inquiries on safety topics related to regulatory filings Prepare for and participate in regulatory agency advisory committees Review and assist in development of Pediatric Investigation Plan (PIP) Prepare for and attend health authority meetings involving patient safety issues. Safety Governance Leadership Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents) 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, key opinion leaders) on safety-related topics. Identify KOL for safety issues and initiate contract process. Provide safety input to support legal needs Managerial and supervisory responsibilities Oversees day to day activities of the Global Safety Officers and Global Safety Physicians as applicable Ensure staff are compliant with Amgen corporate and departmental training and SOP review Provide training, coaching, mentoring, and development of staff Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes 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 MedDRA and other dictionaries used in pharmacovigilance Methods of qualitative and quantitative safety data analysis Product and disease state knowledge or ability to consolidate knowledge from publications, and medical platforms (eg uptodate: open evidence) Foundational knowledge in 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 Other skills Strategic thinking Adaptable growth mindset – able to implement new platforms Ability to self-educate on complex medical, manufacturing or pharmacology concepts as needed Effective team and strategic leadership, influencing, and negotiation in a cross-functional, matrix environment Big picture perspective and context analysis People team time and prioritization management Conflict management Organization, prioritization, and planning of work Project management Critical scientific assessment and problem solving Oral presentation skills including the ability to convey complex scientific data in a concise way to different levels of management Written communications and medical/scientific writing Computer skills (e.g., MS Office Suite and safety systems) Competencies KNOWLEDGE Serves as a technical authority within the organization Develops advanced/leading-edge technologies and/or concepts that have global reach and applicability Foundational knowledge base required and the ability to use external sources to self-educate on key safety issues and adjacent information PROBLEM 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 Education & Experience (Basic) MD or DO degree from an accredited medical school with 6 years of directly related experience OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Education & Experience (Preferred) MD or DO degree from an accredited medical school with 6 years of directly related experience or PhD with 15 years of directly related experience Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Experience in Obesity and/or Cardiometabolic conditions 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Previous product safety experience .Salary Range DKK - DKK