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Souvik Hati

@souvikhati1

Pharmacovigilance Drug Safety Associate specializing in global ICSR processing, quality control, and regulatory compliance.

India

Message

What I'm looking for

I’m looking to deepen my impact in global drug safety operations—owning complex case quality, quality control, and regulatory compliance—while contributing to workflow efficiency, training, and audit-ready pharmacovigilance delivery.

I’m a Pharmacovigilance professional nearing 5 years of experience in Global Drug Safety Operations, focused on end-to-end ICSR processing, signal detection support, aggregate safety data handling, and benefit-risk evaluation support. I’m recognized as an SME in complex case handling, including pregnancy, medical device, and literature cases, with a track record of improving case quality, compliance, and workflow efficiency.

In my current role, I handle 150–600 cases per month across triage, data entry, medical coding, and peer review through quality control. I conduct seriousness, causality, and expectedness assessments to ensure global regulatory compliance, execute MedDRA coding and WHO-DD classification with high accuracy, and support pregnancy case reconciliations for Periodic Safety Update Reports.

I’ve built strong operational strengths across Argus Safety, Veeva Safety, and Oracle Inform (EDC), including E2B R2/R3 case processing and E2B authority number handling. I also support audit and inspection readiness, contribute to training and knowledge transfer initiatives, and drive quality improvements through RCA, CAPA, and process simplification efforts.

Experience

Work history, roles, and key accomplishments

Current

Drug Safety Associate II

Current

Novo Nordisk

Sep 2023 - Present (2 years 8 months)

Performed end-to-end ICSR processing (150–600 cases/month) including triage, data entry, medical coding, and peer review, ensuring global regulatory compliance. Served as SME for pregnancy and medical device safety cases, supported PSUR pregnancy reconciliations, and improved case quality through workflow and deviation-reduction initiatives.

MedDRA Coding WHO DD Classification PSURs Audit Readiness

Drug Safety Associate I

Novo Nordisk

Aug 2022 - Aug 2023 (1 year)

Managed high-volume pharmacovigilance case workflows with a focus on accuracy and compliance. Executed content transfers between Argus and CCGloW, performed coding/validation/reportability assessments, supported regulatory audits, and led process simplification via SOP change requests.

CCGloW Coding Validation Regulatory Audit Processes Process Improvement Query Management

Drug Safety Associate (Trainee)

CareerNet Technologies Pvt. Ltd.

Aug 2021 - Aug 2022 (1 year)

Processed ICSRs in the Argus Safety database, completing narrative writing, date-of-birth review, follow-ups, and case validation/clean-up/closure activities. Handled E2B R2/R3 cases from regulatory authorities and supported SOP review, manual QC, KPI tracking, and RCA/CAPA activities for time-limit and amendment issues.

Narrative Writing Date Of Birth Review E2B R2 R3 Processing Risk Management Plan Checks KPI Tracking Root Cause Analysis CAPA

Pharmacist In-Charge

Ayushi New Life Medical

Oct 2020 - Aug 2021 (10 months)

Managed dispensing, inventory control, and patient counseling while ensuring compliance with pharmacy and regulatory standards. Delivered reliable day-to-day pharmacy operations with a focus on patient safety and adherence to process requirements.

Inventory Management Patient Counseling Pharmacy Compliance & Compliance Medication Management Documentation Customer Service

Pharmacist In-Charge

Kalimata Medical Hall

Jan 2018 - Mar 2019 (1 year 2 months)

Provided patient-centric pharmaceutical care and medication management to support safe, effective use of medicines. Ensured ongoing compliance with pharmacy regulations and operational standards.

Medication Management Dispensing Patient Counseling Compliance Monitoring Documentation