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.