Organization: Global Patient Safety
Team: PV Operations
Group Purpose: To provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products. To support global individual case safety reports regulatory reporting compliance.
Job Summary:
- To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)
- Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports.
- To act as a point of contact for Case Management on medical content of ICSRs
Key Activites:
- Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
- Execute ICSR case escalation as appropriate
- Execute appropriate case follow up per SOPs
- Support medical coding conventions, and systematic process improvements for ICSR medical review
- Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems.
- Support Quality Assurance of ICSR medical review (if applicable)
- Provide input on teams for interdepartmental and cross-functional initiatives including, process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review (if applicable)
- Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor
Inspection Readiness:
- 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
Knowledge and Skills :
- Knowledge of Amgen Medical review and Case Management SOPs and regulatory requirements for pharmacovigilance
- Clinical knowledge of therapeutic area patient populations and drug class
- Proficiency in technical safety systems including Safety Database and medical coding
- Knowledge of safety data capture in Clinical Trials and Post Marketing setting
- Knowledge of clinical trials and drug development
- Knowledge of Amgen products and patient population (preferred)
Education & Experience (Basic):
- MD/DO or international equivalent and 1 year of related drug safety experience
Education & Experience (Preferred) :
- MD/DO or international equivalent plus 3 years of relevant work
