Santanu Laha
Bengaluru
Summary
Dynamic Pharmacovigilance professional with 4 years 7 months of experience in end-to-end Individual Case Safety Report (ICSR) processing, including data entry, duplicate checks, seriousness and expectedness assessment, MedDRA coding, narrative writing, and causality evaluation. Experienced in case triage, prioritization, and processing across Clinical Trial, Post-Marketing Surveillance, spontaneous, interventional, non-interventional, legal, and literature cases. Supporting aggregate safety reports and regulatory submissions. Proficient in Argus, ARISg, LSMV, and Rave databases, ensuring strict compliance with global pharmacovigilance regulations and SOPs. Skilled in regulatory reporting, case investigation, quality checks, and aggregate report preparation. A dynamic team player with proven ability to work under pressure, manage time effectively, and mentor new team members while maintaining high-quality safety reporting standards.
Overview
5
5
years of professional experience
1
1
Certification
6
6
years of post-secondary education
Work History
Operation Specialist 1
IQVIA RDS Private Ltd
05.2021 - Current
- Experienced in end-to-end ICSR processing, including data entry, duplicate checks, seriousness assessment, expectedness evaluation, MedDRA coding, narrative writing, and causality assessment
- Processed adverse event reports from all source types with complete and accurate data entry into pharmacovigilance safety systems and also experienced in Inline quality review, End of line Quality review.
- Performed data correction as regulatory guideline
- Determined seriousness, expectedness, reporter causality, suspect drug relationship, and overall case outcome in accordance with regulatory requirements
- Ensured correct identification and selection of suspect and concomitant drugs within the pharmacovigilance safety database
- Skilled in case triage and case prioritization to ensure timely regulatory reporting
- Processed safety cases across Clinical Trial, Post-Marketing Surveillance, spontaneous, interventional, non-interventional study, legal, and literature cases
- Authored high-quality case narratives summarizing all relevant clinical and medical information for Individual Case Safety Reports (ICSRs)
- Performed MedDRA coding of adverse events, medical history, and indications using standardized medical dictionaries
- Applied medical and clinical expertise to ensure data accuracy, consistency, and completeness within safety databases
- Initiated and managed case investigations, including query generation, tracking, and follow-up with reporters in collaboration with local affiliates
- Performed quality checks and case reviews to maintain high data quality standards
- Developed understanding of case clean-up processes supporting aggregate safety reports and regulatory submissions
- Utilized safety databases including Argus, ARISg, LSMV, and Rave for case processing and clinical trial data review
- Ensured compliance with global pharmacovigilance regulations and internal SOPs throughout the case lifecycle
- Supported audit readiness through consistent quality-focused case handling
- Provided mentoring and training support to new team members
Education
Master of Pharmacy - Pharmaceutical Chemistry
College Of Pharmaceutical Sciences, Biju Patnaik University Of Technology
Berhampur, Ganjam, Odisha 07.2016 - 07.2018
Bachelor of Pharmacy - Pharmacy
College Of Pharmaceutical Sciences, Biju Patnaik University Of Technology
Berhampur, Ganjam, Odisha 07.2012 - 07.2016
Skills
- Proficient in Argus data analysis
- ARISg proficiency
- Proficient in LSMV databases
- MedDRA terminology expertise
- Engaging narrative development
- Regulatory adherence
- ICSR management
- Proficient in Microsoft Office
- Safety event analysis
- Literature review
- Effective case prioritization
- Signal analysis
- Risk assessment
- Safety Surveillance
- Legal document processing
- Compliance with regulatory guidelines
- Product quality issue resolution
- Good Pharmacovigilance Practices
- SOP development
- Data Analysis
- Documentation
- Aggregate Safety Reporting
- Drug design
Certification
- Signal Detection and Causality Assessment at Uppsala Monitoring Center
- Good Clinical Practice at NIDA Clinical Trails Network
- Statistical Reasoning and Algorithms in Pharmacovigilance at Uppsala Monitoring Center
- Practical course on Pharmacovigilance Aggregate reports from SG Pharma trainings at Udemy
Languages
English
Bilingual or Proficient (C2)
Bengali
Bilingual or Proficient (C2)
Odiya
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Timeline
Operation Specialist 1
IQVIA RDS Private Ltd
05.2021 - Current
Master of Pharmacy - Pharmaceutical Chemistry
College Of Pharmaceutical Sciences, Biju Patnaik University Of Technology
07.2016 - 07.2018
Bachelor of Pharmacy - Pharmacy
College Of Pharmaceutical Sciences, Biju Patnaik University Of Technology
07.2012 - 07.2016