Rohit Rokade
Safety Science Analyst | Fortrea |
- Role
- Safety Science Analyst at Fortrea
- Location
- Pune, IN
- LinkedIn followers
- 500 followers
About Rohit Rokade
I am a B. Pharmacy graduate with strong interest in Pharmacovigilance. I have…
Experience
Safety Science Analyst
Jul 2025 — Present · Pune, IN
Case Processing & Adverse Event Management-Perform case intake and triage of safety reports from clinical trials and post-marketing sources.Conduct data entry of adverse events into safety databases.Write patient narratives and code adverse events using MedDRA (for marketed products).Assist in listedness assessment against product labels.2. Regulatory Compliance & Reporting-Submit expedited SAE reports to clients, regulatory authorities, and investigators within required timelines.Assist in the preparation and submission of periodic safety reports (PSURs, DSURs, etc.).Ensure compliance with ICH-GCP, FDA, EMA, and other global regulatory requirements.3. Quality & Documentation-Work within Quality Management Systems (QMS) and follow SOPs and Work Instructions (WIs).Maintain accurate documentation for adverse event reporting across different countries.Support database reconciliation and archival of case/study documents.4. Collaboration & Compliance-Build strong relationships with Pharmacovigilance (PV) and Clinical Safety teams.
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