Pharmacovigilance Operations Manager
About this opportunity
Career Category
Safety
Job Description
The Pharmacovigilance Operations Manager at Amgen oversees the operations of the pharmacovigilance department, including the handling of adverse event reports, risk management, and safety communication. They ensure compliance with global safety regulations and guidelines.
Job Summary
Responsible for:
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
Lead development and delivery of training materials for case management conventions
Support resolution of case related specific queries
Management of multiple business partner relationships for case management
Support reviews of contract wording for case related data exchange
Monitoring compliance regarding regulatory submissions and/or contractual wording for data exchange
Assign tasks within Case Management to direct and indirect reports
Support management of staff within Case Management
Escalation of case processing issues
Audit & external inspection support
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 as defined in Standard Operating Procedures or as requested by his/her supervisor
Key Activities
Day-to-day vendor management issues
Interact with other local safety offices
Ensure case processing timelines for AE intake, triage and submission are met
Assess workload to assist in resource management
Support on-boarding and on-going training of vendors
Attend management meetings with vendors
Support analysis of QC trends
Support generating, communicating, and archiving of reports of QC findings
Support audits of CAPAs and other actions/recommendations for ICSR quality related measures
Perform case review as required
Lead development and delivery of convention-related training material
Support training of local office staff
Perform US case follow up activities
Perform BP reconciliation as required by safety agreement
Generate and distribute performance metrics (submission compliance, volumes, turnaround times)
Support reviews of contract wording for case related data exchange
Support regulatory inspection and support for vendor audits/inspections
Oversee performance monitoring and relay metrics to vendors
Support analysis of QC trends including actions/recommendations
Generate, communicate, and archive report of QC findings
Knowledge and Skills
Understanding of global regulatory requirements for pharmacovigilance
Project leadership experience
Competence in safety systems
Experience in supporting inspections or internal audits
Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
Education & Experience (Basic)
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, AND
Previous experience directly managing teams, projects, programs or directing the allocation of resources
.
Job details
How this role compares
Computed from every other active Pharmacovigilance role in our database, not just this employer's listings.
We currently track 41 comparable Manager Pharmacovigilance roles across 22 biopharma companies.
Salary context
7 of 41 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 41 comparable roles
+ 9 more countries
Seniority mix
41 of 41 peers have a known seniority level
Therapeutic area mix
0 of 41 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.