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Safety & Pharmacovigilance Specialist 1

2 weeks ago

Gurugram Hyderabad, India Syneos Health Full time ₹ 8,00,000 - ₹ 12,00,000 per year

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.