Job Summary

Safety PV Specialist (SS I / SS II / Sr SS) - Night Shift
Responsibilities
- Must have 6 + yrs of experience in ICSR case processing and Quality Check / Quality Review.
- Applicants should be willing to work in night shift.
- The work location is Hyderabad / Gurugram, candidate should be willing to work at Hyderabad / Gurugram office.
- 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

📌 Safety & PV Specialist (SS I / SS II / Sr SS) (Gurugram)
🏢 Syneos Health
📍 Gurugram