Sr. Safety & PV Specialist (Night Shift)

Syneos Health; Hyderabad, Gurugram District; On-site; INR 600,000 - 900,000; Full time

Job summary

Syneos Health in Hyderabad seeks a Pharmacovigilance data entry specialist to support receipt and tracking of ICSR in PVG systems. You will assist in ICAR processing, triage reports, and encode data into safety databases, ensuring completeness and regulatory readiness.

The role involves coding of events, medical history, and tests, compiling narratives, and identifying information gaps for follow-up. You will help generate timely safety reports, maintain tracking, and support TMF documentation

Responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• Assists in the processing of ICARS as required.
• Triages ICARS, 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 IC
• Identification and management of duplicate IC
• Activities related to SPOR / IDMP.
• Quality review of IC
• 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.

Job description

Role & responsibilities

Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.

• Assists in the processing of ICARS as required.
• Triages ICARS, 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 IC
• Identification and management of duplicate IC
• Activities related to SPOR / IDMP.
• Quality review of IC
• 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.