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.
Bachelor's degree and 2 years of Scientific or Drug Safety experience
Associate's degree and 6 years of Scientific or Drug Safety experience
High school diploma / GED and 8 years of Scientific or Drug Safety experience
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.