Shatarupa Seth
Pharmacovigilance Officer | 3+ Years in ICSR Case Processing, MedDRA, Argus | Adverse Event Reporting | Drug Safety Compliance | GVP & Regulatory Submissions Expert
- Role
- Pharmacovigilance Officer at Wipro
- Location
- Haora, WB, IN
- LinkedIn followers
- 500 followers
About Shatarupa Seth
As a Pharmacovigilance Officer with over 3 years of experience in the life sciences industry, I specialize in ensuring patient safety through meticulous adverse event reporting, signal detection, and regulatory compliance. My expertise lies in end-to-end ICSR case processing, medical coding using MedDRA, and working with global safety databases like Oracle Argus.I have a proven track record of timely and high-quality submissions in compliance with global pharmacovigilance standards including GVP and FDA/EMA regulations. My collaborative approach allows me to work seamlessly across cross-functional teams to maintain product safety and uphold regulatory excellence.Passionate about drug safety, continuous learning, and driving process improvement, I am committed to contributing to a culture of quality and vigilance in pharmacovigilance operations.
Experience
Pharmacovigilance Officer
Oct 2021 — Present · Kolkata, IN
Process and evaluate Individual Case Safety Reports (ICSRs) in compliance with global regulations and client SOPs.2. Perform accurate MedDRA coding and narrative writing for adverse event cases.3. Utilize Argus Safety to enter, track, and submit AE cases to global health authorities (EMA, FDA, etc.).4. Conduct quality control (QC) of cases and contribute to continuous process improvement.5. Collaborate with cross-functional global teams to ensure timely reporting and regulatory compliance.6. Supported successful audits and inspections with 100% compliance on documentation and timelines.
Education
NSHM Knowledge Campus, Kolkata Group of Institutions 277
Bachelor of Pharmacy - BPharm
2015 — 2019
NSHM Knowledge Campus, Kolkata Group of Institutions 277
Mpharm
2019 — 2021
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