Safety & PV Specialist

Job description

**Role & 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.