Vijay S.
Regulatory Medical Writer | Clinical Trial Transperancy | QC review of regulatory documents | CSR narrative drafting and QC | ICSR case processing | ARISg/ARGUS | MS-SQL | Advance Excel
- Role
- Regulatory Medical Writer at SIRO
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
Experience
Regulatory Medical Writer
Aug 2023 — Present · Thane, IN
Clinical Trial Transperancy (drafting result registration form, protocol registration form, and EudraCT registration form).2. Acting as primary QC reviewer for regulatory medical documents including CSP, CSR, BD, PIP, CSP amendments, PIP waiver, Bridging reports, etc.3. Writting and reviewing of CSR narratives.
Education
Maharashtra Institute of Pharmacy, Pune.
Master's Degree, Quality Assurance Techniques
2012 — 2014
DSTS Mandal's College of Pharmacy
Bachelor's Degree, Pharmacy
2008 — 2012
D.B.F. DAYANAND COLLEGE OF ARTS & SCIENCE. DAYANAND NAGER, RAVIWAR PETH-SOLAPUR-413002.
HSC
2007 — 2008
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