Sr Medical Dir Global 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 supervisingandcontributing totheir 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 whileremainingaccountable for the activities (e.g.validatea 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 safetysubmissionsandresponses or strategic deliverables including but not exclusive to Safety sections of NDAsubmissions, clinicaloverview, 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 orparticipatesin 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])

• Identifyrelevant 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 documentsand 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)

• Analyzesafety data from clinical studies andcontribute to core safety messages and conclusions inclinical study reportsand 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 findingsandvalidatesignalsiteratively asneeded anddocument inappropriate managementsystems.

• Prepares and presents recommendations on safety issueswith medical andindicationcontextincludingsafety data and literature with relevantindicationandcompetitorinformation, tothe Global Safety Team and escalates asappropriate tothe executive level cross-functional decision-making body

• Approves the safety assessment report

Risk management and minimization

• Ensuretimelypreparation, 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 foradditionalrisk minimization measures as applicable to role

Periodic (aggregate) safety reporting

• Ensuretimelypreparation 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,Reviewsandapproves filingdocuments 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 andparticipatein regulatory agency advisory committees

• Review andassistin development ofPediatricInvestigation 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 andmaintaina 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.IdentifyKOL for safety issues andinitiatecontract 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 fordisseminatingandrepresentingcorporate 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 knowledgeor ability toconsolidateknowledge from publications, and medical platforms (eguptodate: open evidence) 

• Foundational knowledge inGeneral medicine, epidemiology, physiology, and pharmacology

• Internal organizational and governance structure

• Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and productlabelling

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 teamtime and prioritizationmanagement

• Conflict management

• Organization, prioritization, and planning of work

• Project management

• Critical scientific assessment and problem solving

• Oral presentation skillsincluding the ability to convey complex scientific data in a concise way todifferent levelsofmanagement

• 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 toself-educateon key safety issues andadjacent information

PROBLEM SOLVING

• Applies global thought leadership

• Shapes long-term strategic direction and reputation of Amgen

• Providesauthoritative 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 ofdirectly relatedexperience
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 ofdirectly relatedexperience or PhD with 15 years ofdirectly relatedexperience

Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

Experience inObesity 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

Previousproduct safety experience