Safety Specialist

• assist with safety and pharmacovigilance program delivery activities including collection, processing, and reporting of individual cases safety reports (ICSRs)
• literature screening for safety, drug coding, maintenance of drug dictionary, MedDRA coding
• data management activities including cleaning and validation of data
• identification of Medicinal Products (IDMP) activities and preparation of expedited and periodic safety reports
• adheres to data privacy guidelines, GCP, GVP, regulatory guidelines, company and project/program-specific procedures
• enter information into PVG quality and tracking systems for receipt and tracking ICSR
• assist in the processing of ICSRs according to SOPs
• triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability
• maintains safety tracking for assigned activities
• performs literature screening and review for safety
• ensures all relevant documents are submitted to the Trial Master File (TMF)
• participates in audits as required/appropriate

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Safety & PV Specialist I