Darshana Patel
Lead Associate-Drug Safety -Clinical and Post marketing end to end PV experience (REMS/Risk Management Plans/ signal management/PVA/ Patient Support Program/ Vendor oversight)
- Role
- Lead Associate-drug Safety at Dr. Reddy's Laboratories
- Location
- Hillsborough, NJ, US
- LinkedIn followers
- 500 followers
About Darshana Patel
Having 16 years of extensive PV experience working with various CROs and pharmaceutical companies ( early phase clinical trials management and clinical safety as well as post marketing safety) End to end PV activities including REMS, writing various aggregate reports, signal management, risk management plans, ICSR management, SDEA activities and compliance, PV due diligence, PV audits, PV vendor oversight, PV inputs in Patient support programs, representing PV in cross functional teams, contributing to PV trainings. Database: Argus, ArisG, LSMV, LSMI, Karomi
Experience
Lead Associate-drug Safety
Aug 2022 — Present · Princeton, NJ, US
Oversaw Risk Evaluation and Mitigation Strategies (REMs) and Risk Management Plans (RMPs) for drug safety initiatives. • Managed REMS inspections and partner audits to ensure compliance and quality assurance. • Provided vendor oversight for patient support programs and trained contractors on pharmacovigilance activities. • Developed Standard Operating Procedures (SOPs) for local pharmacovigilance activities in the USA and Canada.Experienced in PV deviation/CAPA management
Education
NOOTAN PHARMACY COLLEGE, VISNAGAR 232
M.Pharm, QA
2016 — 2018
S.K.Patel college of pharmacy, Kherva
Bachelor's degree, Pharmacy
2000 — 2004
Skills
- Quality Assurance
- Pharmaceutics
- Pharmacovigilance
- Ich-Gcp
- Gcp
- CRO
- Clinical Trials
- Sop
- Clinical Research
- Training
- Regulatory Submissions
- Meddra
- Regulatory Affairs
- Fda
- Drug Safety
- Validation
- Gmp
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