Safety & PV Coordinator

Job Responsibilities

• - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• - Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
• - Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
• - Enters data into safety database.
• - Codes events, medical history, concomitant medications, and tests.
• - Compiles complete narrative summaries.
• - Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
• - Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• - Maintains safety tracking for assigned activities.
• - Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
• - Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• - Manual recoding of un-recoded product and substance terms arises from ICSRs.
• - Identification and management of duplicate ICSRs.
• - Activities related to SPOR / IDMP.
• - Quality review of ICSRs.
• - Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
• - Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
• - Fosters constructive and professional working relationships with all project team members, internal and external.
• - Participates in audits as required/appropriate.
• - Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

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