Harshit Mehta
Senior Medical Safety Lead at Novartis
- Role
- Senior Medical Safety Lead at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Harshit Mehta
Dr. Harshit Mehta, is a medical graduate (MBBS) from TNMC & Nair Hospital in Mumbai. He…
Experience
Senior Medical Safety Lead
Nov 2018 — Present · Hyderabad, IN
Safety lead for early development and post-marketing drugs. • Safety inputs for clinical, safety and regulatory deliverables including concept sheet, clinical study protocol, clinical study reports, IB, DSUR, PSUR,PADER• Submission for early development drug and providing inputs in SCS, SCE, CSR, ADR selection for label and initial development of CDS. •Signal detection and development of RMP. •Member of safety management team (SMT), clinical trial team (CTT), global clinical team (GCT) and acted as the deputy of Global Program Safety Lead (GPSL) in CTT, GCT and SMT.
Education
Maharashtra University of Health Sciences
M.B.B.S.
1998 — 2004
Skills
- Gcp
- Medical Writing
- Sop
- Hospitals
- Ich-Gcp
- Medicine
- Phase I
- Good Clinical Practice (Gcp)
- Clinical Trials
- Standard Operating Procedure (Sop)
- Meddra
- Clinical Research
- Oncology
- Protocol
- Pharmacovigilance
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