DWAIPAYAN DAS
KOLKATA
Summary
Experienced Pharmacovigilance Specialist with 3 years of expertise in drug safety surveillance. Adept at managing end-to-end pharmacovigilance processes, including adverse event reporting, signal detection and risk benefit analysis for various therapeutic areas. Expert in medical coding using MedDRA and WHO-Drug dictionaries, with a strong track record of mentoring new hires and reviewing ancillary documentation. Masters in Pharmacy and effective communication in English and Hindi. Seeking a Drug Safety Associate position at a company where I can leverage my expertise in case processing and medical assessment to support the company's drug safety regulations while striving to meet and exceed performance metrics. Enthusiastic about maintaining the highest standards of case processing and contributing to the company's drug safety mission.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Pharmacovigilance Specialist
Wipro
Kolkata
05.2021 - Current
• Proficient in using industry-standard databases such as Argus safety and Oracle.
• Ensuring Compliance with global regulatory requirements (FDA, EMA, ICH)
• Led cross-functional teams in the preparation and submission of Periodic Safety Update Reports (PSURs), ICSR and Risk Management Plans, contributing to successful regulatory audits with zero findigs.
• Perform medical coding using MedDRA and WHO-Drug dictionaries.
• Worked as a QC (Peer reviewer) in the same project.
• Workplace shadowing and mentoring experienced ones regarding new updates.
• Identified and researched product safety reports.
• Contacted consumers and health professionals regarding incidents.
• Prepared reports and presentations to inform decision-making.
• Maintained comprehensive clinical database for team.
Education
Masters of Pharmacy - Pharmaceutics
Gupta College of Technological Sciences
Asansol, WB08-2021
Skills
- Project Management & Organizing
- Communication and Collaboration
- Confident
- Strong work ethic
- Team Player
- Continuous Learning & Adaptability
- Argus
- MedDRA
- MS Excel
- Data Capture and Analysis
Certification
- Diploma Course in Information Technology Application of Twelve month’s duration with grade A.
- Industrial training in Caplet India Private Limited, Kolkata
- Registered Pharmacist under WB council of Pharmacy (A-19097)
Languages
English
First Language
Hindi
Advanced (C1)
C1
Timeline
Pharmacovigilance Specialist
Wipro
05.2021 - Current
Masters of Pharmacy - Pharmaceutics
Gupta College of Technological Sciences
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