Dattatraya Suresh Kadam
Pune
Summary
Detail-oriented Pharmacovigilance Quality Reviewer with 6 years of experience ensuring high-quality, compliant Individual Case Safety Reports (ICSRs) across global markets. Strong expertise in MedDRA coding, case quality review, and audit readiness. Proven ability to identify quality gaps, provide constructive feedback, and support continuous improvement while meeting strict regulatory timelines.
Overview
3
3
Languages
8
8
years of professional experience
Work History
Quality reviewer
Tata consultancy Services
Pune
10.2023 - Current
- Ensured high standards as quality reviewer for serious ICSRs prior to case release.
- Mentored junior reviewers, strengthening skills through targeted guidance.
- Trained new associates on effective case processing, screening, and triage techniques.
- Provided feedback and resolved queries related to case processing for trainees and processors.
- Conducted retrieval and correction analysis to enhance operational accuracy.
- Participated in daily discussions to address case processing errors and updates.
- Engaged in client calls to discuss updates and resolve errors efficiently.
Case processor
Tata consultancy Services
Pune
06.2020 - 09.2023
- Coding of AEs, cause of death, indications and medical histories using MedDRA.
- Responsible for identifying duplicate/invalid ICSRs, case processing in ARGUS.
- Meet productivity and quality targets.
Pharmacy Consultant
Royal western India turf club, LTD
Pune
10.2019 - 01.2020
- Issued medications from hospital pharmacy to trainers and horses per physician prescriptions.
- Conducted daily inventory checks and compiled monthly stock reports.
- Received shipments of medications from suppliers, ensuring accuracy and completeness.
- Prepared billing for medication dispensed to horses according to physician prescriptions.
Hospital Pharmacist
Sancheti hospital Shivajinagar
Pune
08.2018 - 10.2019
- Dispensing medication counselling patient on proper medication use.
- Maintaining patient and supply records.
- Billing of the medication issue as per the prescription of the doctor.
- Drug inventory, Purchasing, Receiving and supply management.
- Handling Karishma software for billing and patient record.
Education
M. Pharma - Pharmacology
Modern college of Pharmacy
Nigdi, Pune01.2017
B. Pharm -
Dr. D. Y. Patil college of pharmacy
Akurdi, Pune01.2015
Skills
- End-to-end ICSR processing (Data Entry, triage)
- Seriousness, expectedness, and causality assessment
- Knowledge of global PV regulations (EMA, FDA, MHRA, ICH)
- Strong understanding of GVP modules (especially Modules I, VI, and IX)
- MedDRA coding and WHO Drug Dictionary
- Case processing
- Team collaboration
- Client communication
Languages
English
Advanced
C1
Hindi
Advanced
C1
Marathi
Advanced
C1
Tools
- Hands-on experience with PV systems:
Argus Safety
PVAI
Viva Vault Safety
- Data reconciliation and case follow-up tracking
- Excel (pivot tables, trackers, basic analysis)
- Familiarity with QA/QC checklists and workflows
Timeline
Quality reviewer
Tata consultancy Services
10.2023 - Current
Case processor
Tata consultancy Services
06.2020 - 09.2023
Pharmacy Consultant
Royal western India turf club, LTD
10.2019 - 01.2020
Hospital Pharmacist
Sancheti hospital Shivajinagar
08.2018 - 10.2019
M. Pharma - Pharmacology
Modern college of Pharmacy
B. Pharm -
Dr. D. Y. Patil college of pharmacy