Safety & PV Specialist I

Syneos Health is seeking a Safety & PV Specialist I. The successful candidate will be responsible for various safety-related tasks, including entering information into PVG quality and tracking systems, processing ICSRs, triaging ICSRs, evaluating ICSR data, and maintaining safety tracking.

Responsibilities:

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
• Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory reportability.
• Enter data into safety database.
• Code events, medical history, concomitant medications, and tests.
• Compile complete narrative summaries.
• Identify information to be queried and follow up until information is obtained and queries are satisfactorily resolved.
• Assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Maintain safety tracking for assigned activities.
• Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
• Validate and submit xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• Manually recode un-recoded product and substance terms arising from ICSRs.
• Identify and manage duplicate ICSRs.
• Perform activities related to SPOR / IDMP.
• Conduct quality review of ICSRs.
• Ensure 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.
• Maintain 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.
• Foster constructive and professional working relationships with all project team members, internal and external.
• Participate in audits as required/appropriate.
• Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

Qualifications:

• Education: B. Pharm / M. Pharm / BDS / BMS / MBBS.
• Experience: Minimum 2.6 Years to 4 Years in Safety & PV Specialist role.
• Location: Gurugram-Hyderabad Office based.