Director, Pharmacovigilance Operations (MariTide Lead)

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Director, Pharmacovigilance Operations (MariTide Lead)

What you will do

Let’s do this. Let’s change the world. In this vital role you will Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Responsible for overseeing the processing and submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Oversee all interactions with business partners (license 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, including analysis and reporting of 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 AE Intake processes including training, controlled documents and systems for MariTide platform and for Rare Disease portfolio
• Provide Safety Intake expertise for Data Element Standards Committee relating to development and execution of compliant eCRF/CRFs that facilitate accurate and complete clinical trial SAE data and post market AE data are collected in line with global regulatory requirements
• Ensure all Amgen BP/LP PVAs are compliant with global safety legislation and requirements and meet all case management
• Oversee relationship between business partners (external) and PSAM (internal) to ensure capture of all adverse event data generated under PVAs.
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• ICMC point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• 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 (i.e. performance, business, and compliance metrics)
• Manage communications within the ICMC/PV Operations department training programs; participates in development and modification of procedures and training material
• Drive audit CAPAs and other actions/recommendations for and compliance issues are completed documents
• Accountable as liaison between clinical trial and Global Patient Safety to ensure capture of all adverse event data generated by such programs
• Responsible for developing and supporting 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 and contribute to the development, improvement and standardization of new processes and methods
• Lead/Support the implementation of new eSAE processes and methods within and across Global Patient Safety and Global Development Operations
• Develop and maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable
• 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
• Performs other duties related to the position as necessary

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Pharmacovigilance professional we seek is a professional with these qualifications.

Basic Qualifications:

• Doctorate degree and 4 years of Drug Safety or Life Sciences experience