Safety & PV Specialist I (Japanese Language Expert) 21/08/2025

2 weeks ago

Gurgaon, Haryana, India Syneos Health Full time
Job Description

Job Responsibilities

- Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
- Assist in the processing of ICSRs as per Standard Operating Procedures (SOPs) and project/program-specific safety plans.
- Triage ICSRs and evaluate 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 missing information, raise queries, and follow up until resolution.
- Generate timely, consistent, and accurate expedited reports per regulatory requirements.
- Maintain safety tracking for assigned activities.
- Perform literature screening and review for safety, drug coding, and MedDRA coding.
- Validate and submit xEVMPD product records, including indication coding using MedDRA.
- Perform manual recoding of un-recoded product and substance terms from ICSRs.
- Identify and manage duplicate ICSRs.
- Handle activities related to SPOR/IDMP.
- Conduct quality review of ICSRs.
- Ensure submission of relevant documents to the Trial Master File (TMF) and Pharmacovigilance System Master File as per SOP/Sponsor requirements.
- Maintain compliance with SOPs, Work Instructions (WIs), global regulations, GCP, ICH, and GVP guidelines.
- Foster constructive and professional relationships with project team members, internal and external.
- Participate in audits as required.
- Apply safety reporting regulatory intelligence maintained by Syneos Health to safety reporting activities.

Qualifications

- Master's in Pharmacy (preferred) or Master's in Science/Healthcare field, or equivalent combination of education and experience.
- Excellent interpersonal and communication skills.
- Advanced skills in Microsoft Office applications.

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