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Sanket 4141

Sanket 4141

Pharmacovigilance Associate | Drug Safety Specialist

Talent
PuneMember since June 14, 2026
Adverse Drug Reaction (ADR) ReportingIndividual Case Safety Reports (ICSRs)Good Pharmacovigilance Practices (GVP)ICH guidelinesGood Manufacturing Practices (GMP)Quality control proceduresBatch documentationDeviation reportingFDA FAERSVigiBase (WHO-UMC)Periodic Benefit-Risk Evaluation Reports (PBRER)Development Safety Update Reports (DSURs)Good Clinical Practice (GCP)
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Adverse Drug Reaction (ADR) ReportingIndividual Case Safety Reports (ICSRs)Good Pharmacovigilance Practices (GVP)ICH guidelinesGood Manufacturing Practices (GMP)

About

Motivated B.Pharmacy graduate (2025) with academic grounding in pharmaceutical sciences, drug metabolism, clinical pharmacology, and regulatory affairs. Seeking an entry-level Pharmacovigilance role to apply knowledge of adverse drug reaction (ADR) reporting, Individual Case Safety Reports (ICSRs), MedDRA coding, signal detection, and ICH E2 guidelines. Committed to patient safety, data integrity, and compliance with global drug safety regulations including EMA, FDA, and CDSCO requirements.

Experience

Industrial Training / Internship - Jarandeshwar Organics - Karad

Pharmaceutical Manufacturing & Production Unit - 3 Months

  • Observed Good Manufacturing Practices (GMP) and quality control procedures in pharmaceutical production.
  • Gained exposure to batch documentation, in-process quality checks, and deviation reporting – foundational skills directly applicable to pharmacovigilance data management.
  • Assisted in packaging operations, ensuring label accuracy and regulatory compliance – building awareness of post-market product surveillance.

Education

PG Diploma - clinical Research, clinical data management and pharmacovigilance with AI - Savitribai phule pune university

B. Pharmacy - Pharmacy - Krishna Institute of Pharmacy (2025)

Higher Secondary (Science) - Science - Ligade Patil Junior College

Secondary School - Shantineketan

Skills

Pharmacovigilance AssociateDrug Safety Specialist

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