Pharmacovigilance Operations Manager

Amgen

Pharmacovigilance Operations Manager responsible for FDA/EMA safety reporting and vendor oversight for Amgen. Leading compliance and training efforts across local safety offices in patient care.

Posted 5/8/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-Level💰 $116,167 - $157,168 per yearWebsite

About the role

Key responsibilities & impact

Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
Support the submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors
Support interactions with business partners (license partners) and vendors for all case intake and processing activities.
Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures.
Ensuring vendor compliance with approved processes and training requirements.
Audit & external inspection support
Manage multiple business partner relationships for case management
Monitor compliance regarding regulatory submissions and/or contractual wording for data exchange
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

Requirements

What you’ll need

Doctorate Degree
Master’s degree and 2 years of directly related experience or Bachelor’s degree and 4 years of directly related experience or Associate’s degree and 8 years of directly related experience or High school diploma / GED and 10 years of directly related experience
Previous experience directly managing teams, projects, programs or directing the allocation of resources.
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

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

safety reportingindividual case safety reportscase managementvendor oversightcompliance monitoringaudit supportinspection readinesspharmacovigilancesafety systemsproject leadership

Soft Skills

team managementproject managementresource allocationinterpersonal communicationrelationship management

Certifications

Doctorate DegreeMaster’s DegreeBachelor’s DegreeAssociate’s DegreeHigh School Diploma / GED