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Amgen logo
Amgen

Founded in 1980, Amgen (short for Applied Molecular Genetics) is a biotechnology firm focused on developing human therapeutics. As an employer, Amgen has been d

Pharmacovigilance Operations Manager

Location

United States

Posted

37 days ago

Salary

$116.2K - $157.2K / year

Seniority

Mid Level

2 yrs expEnglish

Job Description

Pharmacovigilance Operations Manager

Amgen

• 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

Job Requirements

  • 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

  • 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

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