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Job Description
Inviting Applicants for Aggregare Report Scientist
Location: Pune (Work From Office)
Key Responsibilities:
✅ Prepare and manage PSURs/PBRERs using approved templates and processes.
✅ Retrieve and review prior safety documents while coordinating inputs from cross-functional stakeholders and Vendor Affiliate Partners (VAPs).
✅ Lead end-to-end PSUR planning and execution
✅ Perform comprehensive medical review and safety analysis to ensure accurate benefit-risk evaluation.
✅ Manage contributor reviews, Quality Control (QC) reviews, and QPPV review cycles while addressing stakeholder comments and ensuring compliance with regulatory standards.
✅ Drive the finalization, approval, publication, and archival of PSURs, including coordination with Regulatory Affairs Operations and region-specific submission requirements.
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Do
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Ensure process is executed as per the client contract
- Conduct briefings before every shift to drive focus on key metrices and debrief at the end of the shift to drive focus of the team on quality and adherence to contract compliance processes
- Prepare notes from the huddle meetings and share it with the team
- Prepare and share the performance data of the team with the client at the end of the shift
- Interact with the client and prepare note to share updates and changes with the team
📌 First Line Manager (Pune)
🏢 Wipro
📍 Pune