Pharmacovigilance Operations Manager in Cambridge

In this vital role your primary responsibility will be acting as the US/EU local safety office and FDA/EMA point of contact for safety reporting. You will support the submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors; oversee interactions with business partners and vendors for all case intake and processing activities; ensure vendor compliance with approved processes and training requirements; and support audit and external inspection activities.

What You Will Do

• Support ICSR processing to ensure high‑quality cases in a timely manner to meet all worldwide regulatory authority requirements.
• Provide vendors with resources and training to perform their role.
• Support the analysis and communication of case QC results and the development of training materials for case management conventions.
• Support resolution of case‑related specific queries and manage multiple business partner relationships for case management.
• Review contract wording for case‑related data exchange and monitor compliance regarding regulatory submissions.
• Assign tasks within Case Management to direct and indirect reports and support the management of staff within Case Management.
• Escalate case processing issues and support audit and external inspection activities.
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness.
• Serve as point of contact for Health Authority Inspection and Internal Process Audits within the remit of the role.
• Perform other duties related to the position as defined in Standard Operating Procedures or as requested by the supervisor.
• Handle day‑to‑day vendor management issues, interact with other local safety offices, and ensure case processing timelines for AE intake, triage, and submission are met.
• Assess workload to assist in resource management; support onboarding, ongoing training of vendors; attend management meetings with vendors.
• Support analysis of QC trends, generate, communicate, and archive reports of QC findings, and support audits of CAPAs and other actions for ICSR quality measures.
• Perform case review as required; lead development of convention‑related training material; train local office staff.
• Perform US case follow‑up activities, perform BP reconciliation as required, and generate and distribute performance metrics (submission compliance, volumes, turnaround times).
• Support reviews of contract wording for case‑related data exchange, support regulatory inspection, and oversee performance monitoring and relay metrics to vendors.
• Generate, communicate, and archive reports of QC findings.

What We Expect Of You

• Understanding of global regulatory requirements for pharmacovigilance.
• Project leadership experience.
• Competence in safety systems.
• Experience supporting inspections or internal audits.
• Proficiency with Microsoft Suite: Word, Excel, PowerPoint, Project, and Outlook.

Education

• Master’s degree and 3 years of directly related experience, or Bachelor’s degree and 5 years of directly related experience, or Associate’s degree and 10 years of directly related experience, or High school diploma/GED and 12 years of directly related experience.
• Previous experience directly managing teams, projects, programs, or directing resource allocation.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.