Deepti Gupta
Associate Director-Medical safely, Global Safety Officer
- Role
- Global Safety Officer, Associate Director-medical Safety at IQVIA
- Location
- New Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Deepti Gupta
Pharmacovigilance professional with sound scientific background, excellent analytical and problem-solving skills with overall 16 years of experience and working in the pharmacovigilance industry for more than 12 years. Qualified physician having an in-depth knowledge of end to end pharmacovigilance and expert in pharmacovigilance activities including signal management, presentations to safety governance, aggregate report review and contribution (PBRER, DSUR etc.), Risk Management Plans, response to Health Authority queries, Health Hazard Evaluation, handling product alert, CCSI maintenance, benefit risk assessment. I have faced audits and inspections and worked on development of company’s Standard Operating Procedures (SOPs) & Work Instructions with focus on quality.
Experience
Global Safety Officer, Associate Director-medical Safety
Oct 2018 — Present
PV expertise for assigned products, maintains PV expertise, and understanding of international safety regulations and guidelines• Signal Management : Signal detection, validation, assessment, presentation to Safety governance• Responsible for drafting, reviewing and validating periodic reports, Benefit-Risk analyses documentation, RMP update, Health Hazard Evaluation, managing product safety alert, Preparation of clinical overview to support labelling changes and oversees the safety part of the Company Core Safety Information (CCSI) creation, attending Labelling Working Groups and Labelling Review Committee meetings.• Product safety alerts handling, providing safety expertise for participation in meetings with Health Authorities as required including Direct Healthcare Communication related documentation.
Education
Institute of Good Manufacturing Practices India (IGMPI)
Dip, Medical writing
2018 — 2019
Governement Medical college, Miraj, Maharashtra
Bachelor of Medicine, Bachelor of Surgery (MBBS)
1999 — 2004
Institute of clinical research, New Delhi
Diploma Clinical Research
2010
The ICFAI University, Tripura
Master of Business Administration - MBA, Pharmaceutical medicine
Skills
- Psur
- Medical Writing
- Arisg
- Meddra
- CRO
- Gcp
- Medical Affairs
- Clinical Trials
- Clinical Development
- Clinical Research
- Ich-Gcp
- Clinical Data Management
- Drug Safety
- Pharmacology
- Ctms
- Pharmacovigilance
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