Deepak K.
Senior Specialist (Computer System Validation l Data Migration l MedDRA upgrade, Change request l ICSR processing (Ab-Cube| Avoxi |Smartmed lSapphire l Docubridge |Vigicontract (Regulatory Affairs) l Master control(RnD)
- Role
- Senior Specialist (Pharmacovigilance Epidemiology & Risk Management) at PharmaLex
- Location
- Aligarh, UP, IN
- LinkedIn followers
- 500 followers
About Deepak K.
Pharmacovigilance Healthcare Professional expertise in Pharmacovigilance, ICSR case processing and computerized system validation for databases adapt at ensuring regulatory compliance and optimizing pharmacovigilance operations to enhance pateint safety.*Proven expertise in managing ICSR and Aggregate reports ensuring accuracy and regulatory alignment*Experienced in MedDRA/WHO-DD upgrades and IQ, OQ and PQ documentation, supporting system enhancements and regulatory submissions.*Familiar with multiple safety databases Safetyeasy, Avoxi, Smartmed info, Vigi contract and Regulatory databases (Zendesk and Docubridge ) QMS database (Mastercontrol and ZenQMS)*Well understood the GAMP 5, EU Annex 11 and 21CFR part 11.*Phytochemical investigation and pharmacological screening of Gymnema sylvestre project have been done
Experience
Senior Specialist (Pharmacovigilance Epidemiology & Risk Management)
Dec 2023 — Present
Education
SHIVDAN SINGH INSTT. OF TECH. & MANAGEMENT IGLAS, ALIGARH
B.pharm
2013 — 2017
ITS college of Pharmacy Muradnagar
M.pharma
2017 — 2019
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.