Hitesh Raulkar
Cognizant | Senior Process executive - Pharmacovigilance| Drug Safety & Risk Management | ICSR & Case Processing
- Role
- Senior Process Executive (Spe) - Pharmacovigilance at Cognizant
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Hitesh Raulkar
Detail-oriented Pharmacovigilance Professional with experience in drug safety, clinical data management, and regulatory compliance. Currently working at Cognizant, leveraging expertise in ICSR case processing, MedDRA coding, and adverse event reporting to ensure patient safety and global regulatory adherence.Previously at IKS Health, I built a strong foundation in clinical documentation and medical terminology, developing a keen eye for identifying clinical discrepancies and safety signals in patient data. My background combines technical proficiency in safety databases (e.g, Argus, ArisG) with a deep understanding of global pharmacovigilance guidelines (ICH-GCP, FDA, EMA).I am passionate about advancing public health by maintaining the highest standards of data integrity and safety surveillance throughout the product lifecycle
Experience
Senior Process Executive (Spe) - Pharmacovigilance
Jan 2026 — Present · Pune, IN
Core Responsibility: Manage end-to-end Individual Case Safety Reports (ICSR) processing for global markets, ensuring compliance with regulatory timelines (FDA, EMA, MHRA).Case Processing: Perform data entry, triage, and quality review of adverse events (AEs) from spontaneous reports, clinical trials, and literature sources.Medical Coding: Apply precise MedDRA and WHO Drug coding to ensure accurate classification of adverse drug reactions and concomitant medications.Safety Assessment: Conduct seriousness assessments, causality assessments, and labeling assessments (expectedness) against the Investigator’s Brochure (IB) or Company Core Data Sheet (CCDS).Quality Assurance: Maintain high quality and accuracy standards during case processing to minimize error rates and support successful regulatory audits.Query Management: Collaborate with medical reviewers and safety physicians to resolve medical queries and ensure complete case documentation.
Education
Maharashtra State Board of Secondary and Higher Secondary Education (MSBSHSE)
HIGHER SECONDARY CERTIFICATE (HSC), SCIENCE
Maharashtra State Board of Secondary and Higher Secondary Education (MSBSHSE)
SECONDARY SCHOOL CERTIFICATE (SSC), ENGLISH
Dr. Babasaheb Ambedkar Technological University
Bachelor of Pharmacy - BPharm, Pharmacy
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