Amgen Inc., a leader in biotechnology with a mission to serve patients living with serious illnesses, is hiring a Director, Pharmacovigilance Operations (MariTide Lead). This role acts as the primary US/EU local safety office and point of contact for the FDA/EMA regarding safety reporting for the MariTide platform and our Rare Disease portfolio.
What You'll Do
- Act as US/EU local safety office and FDA/EMA point of contact for safety reporting.
- Oversee the processing and submission of all individual case safety reports to FDA/EMA, business partners, and vendors.
- Oversee all interactions with business partners and vendors for all case intake and processing activities.
- Oversee vendor oversight of all intake case processing for adverse events, and intake/triage of product complaints.
- Analyze and report trends in quality measures for rare disease portfolio.
- Ensure vendor compliance with approved processes and training requirements.
- Provide audit and inspection support.
- Act as business process owner (BPO) and point of contact for AE Intake processes including training, controlled documents and systems.
- Provide Safety Intake expertise for Data Element Standards Committee relating to development and execution of compliant eCRF/CRFs.
- Ensure all Amgen BP/LP PVAs are compliant with global safety legislation and requirements.
- Oversee relationship between business partners and PSAM to ensure capture of all adverse event data.
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.
- Serve as ICMC point of contact for Health Authority Inspection and Internal Process Audits.
- Lead and drive ICMC subject matter expertise for eSAE Governance.
- Evaluate and implement process improvement strategies for ICMC.
- Own process content, deliverables/outputs, and metrics.
- Manage communications within the ICMC/PV Operations department training programs.
- Drive audit CAPAs and other actions/recommendations for compliance issues.
- Accountable as liaison between clinical trial and Global Patient Safety to ensure capture of all adverse event data.
- Develop and support strong cross-functional relationships and communication.
- Develop and communicate plans/objectives to others as needed.
- Maintain knowledge of adverse event collection and reporting process and safety system.
- Contribute to the development, improvement and standardization of new processes and methods.
- Lead/Support the implementation of new eSAE processes and methods.
- Develop and maintain functional area standard operating procedures and contribute to R&D Standards documents.
- Be representative and point of contact for Health Authority Inspection and Internal Process Audits.
What We're Looking For
- Doctorate degree and 4 years of Drug Safety or Life Sciences experience
- Master’s degree and 7 years of Drug Safety or Life Sciences experience
- Bachelor’s degree and 9 years of Drug Safety or Life Sciences experience
Nice to Have
- BS, MPH, RN, HCP, or Life Science degree
- 8+ years of directly relevant experience (including 6 years of experience in Drug Safety)
- Experience in leading and managing teams
Benefits & Compensation
- Compensation: $188,143.00 USD - $227,444.00 USD
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program or sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
Work Mode
This role is a hybrid position based in the United States.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
