Amgen
Safety
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
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
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Salary Range
DKK - DKK