Safety & Pharmacovigilance Specialist 1

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.