Career Category

Safety

Job Description

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

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