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Devansh Desai
Senior Pharmacovigilance Associate
Senior Pharmacovigilance Associate
Devansh Desai is a Pharmacovigilance and Clinical Research professional with over 12 years of experience in drug safety operations, case processing, aggregate reporting, and clinical trial coordination. He has expertise in SAE/AE case handling, MedDRA coding, literature surveillance, and preparation of regulatory submissions including PSURs, PADERs, PBRERs, and RMPs. Devansh has supported end-to-end clinical trial activities—ethics submissions, informed consent, data entry, and subject communication—ensuring adherence to ICH-GCP and regulatory requirements. Known for process ownership, documentation excellence, training delivery, and cross-functional collaboration, he consistently ensures high-quality, audit-ready deliverables in safety and clinical environments.
FORMERLY AT
Oviya MedSafe
LOCATION
Coimbatore
AVAILABILITY
Full-time
Skills
Clinical Documentation Platforms
EDC Systems
MedDRA
Microsoft Office
Regulatory Documentation Systems
Safety Databases (Clinevo)
WHO-DD
Work Experience
Senior Pharmacovigilance Associate
Oviya MedSafe
April 2021 – Present
- Managed operational decisions and allocated case processing activities within the safety team.
- Processed SAE/AE reports, performed MedDRA coding, and ensured compliance with safety database requirements.
- Prepared and reviewed aggregate safety reports including PSURs, PADERs, PBRERs, and RMPs.
- Conducted literature surveillance, authored safety documents, and performed quality checks.
- Delivered training sessions and ensured regulatory documentation was maintained.
TECHNOLOGIES
Safety Databases (Clinevo), MedDRA, WHO-DD, Microsoft Office
Clinical Research Coordinator
Hindusthan Hospital
May 2020 – April 2021
- Coordinated daily clinical trial activities in alignment with ICH-GCP and institutional SOPs.
- Managed informed consent, patient communication, AE/SAE reporting, and data entry.
- Supported ethics committee submissions, monitoring visits, and ensured study documentation accuracy.
TECHNOLOGIES
EDC Systems, Microsoft Office, Clinical Documentation Platforms
Ethics Committee Administration Staff
Sri Bala Medical Centre & Hospital Pvt. Ltd.
May 2017 – April 2020
- Supported ethics committee activities including scheduling meetings, maintaining regulatory records, and managing study submissions and approvals.
- Ensured compliance with guidelines and facilitated communication between investigators and committee members.
TECHNOLOGIES
Microsoft Office, Regulatory Documentation Systems
