ARGUS, SAPPHIRE,LSMV,MS-OFFICE,EXCELL,POWER PONT
BHARATI MANJHI
Senior Process Associate
Nagpur
Summary
Result oriented Pharmacovigilance Associate with 4 years of hands-on experience in ICSR case processing, specializing in case booking, intake, and triage. Strong exposure to Spontaneous, Clinical Trial, and Literature cases, with sound knowledge of medical terminology, global safety regulations, and end-to-end pharmacovigilance workflows. Known for accuracy, compliance, and clear communication within cross-functional teams.
Overview
4
4
years of professional experience
3
3
Languages
Work History
Senior Process Associate
Tata Consultancy Services
Nagpur
04.2021 - 07.2025
- Performed ICSR case booking and triage for Spontaneous, Clinical Trial, and Literature cases in compliance with global regulatory requirements.
- Conducted case intake, ensuring completeness, validity, and accurate source documentation.
- Assessed case seriousness, expectedness, and causality based on available medical information.
- Applied MedDRA coding for adverse events and medical history using latest versions.
- Drafted high-quality case narratives reflecting clear clinical chronology.
- Maintained strict adherence to SOPs, timelines, and quality standards.
- Collaborated with medical reviewers and safety teams to resolve data queries.
- Consistently met productivity and quality benchmarks with minimal rework.
Education
Master of Science - Pharmacy
University Department of Pharmaceutical Sciences
Nagpur, India 04.2001 -
Skills
Soft Skill:
Attention to Detail– critical for accurate ICSR processing
Analytical Thinking – for case assessment and safety evaluation
Time Management – meeting strict regulatory timelines
Clear Written & Verbal Communication – narratives, follow-ups, cross-team coordination
Problem-Solving Ability – handling complex or incomplete cases
Team Collaboration – working with medical, regulatory, and QC teams critical for accurate ICSR processing
Time Management – meeting strict regulatory timelines
Clear Written & Verbal Communication – narratives, follow-ups, cross-team coordination
Problem-Solving Ability – handling complex or incomplete cases
Accountability & Ownership – end-to-end case responsibility
Team Collaboration – working with medical, regulatory, and QC teams
Technical Skills:
End-to-End ICSR Case Processing
Case Intake & Triage
Seriousness, Expectedness & Causality Assessment
MedDRA Coding,WHODrug Coding and Narrative Writing
Literature Case Processing ,Duplicate Case Identification & Resolution as well as Follow-up Management
Quality Check (QC) of Safety Cases
ICH Guidelines,Regulatory Compliance & SOP Adherence
Safety Database Handling (Argus Safety / SAPPHIRE)
Software
Achievement and Awards
Qualified National Entrance Exam GPAT (Graduate Pharmacy Aptitude Test) with 93%- 2018
PROJECTS
- Thesis: B.Pharm "Review article on effect of probiotics on various skin ailments.
- Thesis: M.Pharm "Comparison of Arjuna Ghritas prepared from naturally shaded and marketed Arjuna bark for its cardio protective activity
Timeline
Senior Process Associate
Tata Consultancy Services
04.2021 - 07.2025
Master of Science - Pharmacy
University Department of Pharmaceutical Sciences
04.2001 -