Responsible for providing medical assessment and oversight of individual case safety reports completed by vendors and case processing resources in accordance with applicable regulations and agreements. Supporting current and anticipated activities for medical review and assessment of reports from global development programs.
- Review all high impact cases (e.g. fatal/life threatening SUSARs, unanticipated events, cases where investigator and company causality differ, and others as required) prior to submission to health authorities.
- Provide medical advice and input to the activities of adverse event (AE) case management, including medical review of ICSRs (narrative, coding, labeling, causality, company comment) as well as work closely with PV teams, RM leads and clinical development leads to provide a cohesive, comprehensive and accurate medical narrative, analysis of similar events (when applicable) and company causality rationale in individual case reports prior to health authority submission.
- MD required.
- Clinical experience, with 5 + years of industry experience in pharmacovigilance/ drug safety including significant previous experience in medical review of individual cases.
- Ability to apply and provide critical analysis of relevant clinical information for clinical trial SAE and AESIs. Function as a medical review expert for DOB compounds. Ability to apply PVRM safety database for purposes of medical case review and simple queries. Ability to effectively communicate (verbal and written) medical rationale and defend recommendations in safety narratives.