Amgen Senior Associate Pharmacovigilance Operations in Thousand Oaks, California

Amgen is seeking a Senior Associate Pharmacovigilance Operations to work out of their Thousand Oaks, CA location.

The Pharmacovigilance Department act as US/EU local safety office and FDA/EMA point of contact for safety reporting. They are responsible for the submission of all individual case safety reports to FDA/EMA/BPs.

Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Handle vendor oversight of all case processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements

Audit & external inspection support

The Senior Associate is Responsible for:

  • Performing case review and escalation of case level issues

  • Manage queries on Intake, triage and data entry of Individual Case Safety Reports (ICSRs)

  • Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts

  • Reporting of ICSRs within time frames determined by regulations and contracts

  • Support BP reconciliation as required by safety agreement

  • Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness

  • Be representative for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

  • Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements

  • Support the development and delivery of convention-related training material

  • Review and respond to AE intake, triage and submission queries in a timely fashion

  • Ensure compliance of reporting activities with timelines and criteria

  • Interface with local office staff, vendors and business partners for case processing

  • Escalation of data entry issues identified

  • Provide LAO E2B support (nullification, redistribution)

  • Perform BP reconciliation as required by safety agreement

  • Support the ICSR literature review process.

Basic Qualifications:

Master's Degree

OR

Bachelor's degree and 2 years of Scientific or Drug Safety experience

OR

Associate's degree and 6 years of Scientific or Drug Safety experience

OR

High school diploma / GED and 8 years of Scientific or Drug Safety experience

Preferred Qualifications:

  • BS Degree

  • 2+ Years of working in the Pharmaceutical/Biotech Industry

  • Understanding of global regulatory requirements for pharmacovigilance

  • Familiarity with clinical development process

  • Case processing experience with demonstrated high case level productivity and quality

  • Attention to detail

  • Proficiency in safety system

  • Microsoft Suite experience: Word, Excel, PowerPoint, Project, Outlook

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.