Job Description

Career Category

Safety

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.

•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