Prince Chokker
Pune
Summary
Dedicated Drug Safety Specialist with over 3.5 years of experience in reviewing, assessing, and processing safety data from multiple sources. Expertise in generating detailed safety and aggregate reports to support pharmacovigilance activities. Proficient in Argus Safety, SQL, and MS Excel for efficient data management and analysis. Strong collaborative skills with a proven ability to enhance team performance and optimize operational workflows. Committed to ensuring drug safety compliance and contributing to risk management and regulatory reporting. Ready to leverage my expertise to advance your organization's pharmacovigilance and drug safety initiatives.
Overview
4
4
years of professional experience
7
7
years of post-secondary education
1
1
Certification
Work History
Senior Process Associate
Tata Consultancy Services
Pune
07.2024 - 05.2025
- Acted as Subject Matter Expert (SME) for Argus Safety and case processing workflows.
- Provided SME-level guidance to intake, case processing and review teams.
- Conducted quality reviews and process optimization as SME.
- Processed and triaged global SAE and AE reports from spontaneous, literature, and clinical trial sources. Maintained compliance with MedDRA and WHO-DD coding guidelines and ensured narrative accuracy.
- Trained juniors associates and new joiners on case triage and case processing.
- Supported medical and QA teams in regulatory reporting and safety data submissions.
- Reviewed full-text articles to extract safety-relevant information including patient demographics, drug exposure, dosage, indication, AE/SAE details, outcomes, and dechallenge/rechallenge.
- Participates in effective functioning of PV projects (including Aggregate Reporting, Signal Detection and Management, etc.) in compliance with agreements and applicable regulations and guidelines.
- Handled both global and local literature cases as per client-specific SOPs.
Operations specialist 1
IQVIA
Bangalore
04.2021 - 01.2024
- Review, assess and process safety data received from clinical trail, spontaneous, literature and study sources and distribute reports/data onwards to Client/ Regulatory Authorities on time and quality standards.
- Periodic aggregate safety report writing including PBRER, PSUR and DSUR.
- Enter case data, including but not limited to general information, reporter details, patient details, event details, seriousness, reported causality (when appropriate), medical history, and laboratory data as provided by the reporter.
- Use MedDRA to code information like specified events, medical history, laboratory data, as applicable, as provided by the reporter.
- Code products specified as suspect or concomitant by the reporter using Company Drug Dictionary/WHO Drug Dictionary as needed, provide additional details as needed.
- Enter the narrative, as required, use a lead sentence as appropriate.
- Initiate follow-up activities to obtain additional information and clarification.
- Forward cases for case review or non-valid workflow in the global safety database.
- Perform peer review of all processed cases, prioritizing peer review of cases in ARGUS database based on the case types.
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
- Performed systematic screening of scientific literature from databases such as PubMed, Embase, and Ovid to identify Individual Case Safety Reports (ICSRs).
- Conducted daily screening of abstracts and full-text articles in compliance with global and local regulatory requirements.
Intern
Medanta
- Researched and analyzed antibiotic usage patterns, resulting in a 20% reduction in unnecessary antibiotic prescriptions.
- Collaborated with the healthcare team to develop educational materials, leading to a 15% increase in awareness about antibiotic stewardship best practices among staff and patients.
Education
MBA - Operations Management
Narsee Monjee Institute Of Management Studies
Mumbai 01.2022 - 01/2024
B Pharmacy - Pharmacy
Pt B D Sharma Postgraduate Institute of Medical Sciences
Rohtak, India 08.2013 - 04.2018
12th - Science
South Point Public School
Sonipat, India 05.2012 - 04.2013
10th - English
South Point Public School
Sonipat, India 04.2011 - 03.2012
Skills
- Clinical research
- Team work
- Good communication skills
- Argus safety
- Case processing
- Meddra
- Ich-gcp
- Clinical data management
- Clinical operations
- Aggregate Reporting
- Interpersonal Skills
- Problem Solving
- Analytical Skills
- Operations Management
- Literature Review
- Power Bi
- Dashboards
- MySQL
- Database
- Aggregate Report Writer
Certification
- GCP certificate by NIDA
- GCP training by CDSA
- GCLP Training By CDSA
- PG Diploma in Pharmacovigilance and Clinical Data Management
- Data Analysis Program by Growth School
Languages
- English
- Hindi
- English
Timeline
Senior Process Associate
Tata Consultancy Services
07.2024 - 05.2025
MBA - Operations Management
Narsee Monjee Institute Of Management Studies
01.2022 - 01/2024
Operations specialist 1
IQVIA
04.2021 - 01.2024
B Pharmacy - Pharmacy
Pt B D Sharma Postgraduate Institute of Medical Sciences
08.2013 - 04.2018
12th - Science
South Point Public School
05.2012 - 04.2013
10th - English
South Point Public School
04.2011 - 03.2012
Intern
Medanta