Nikhil Sharma
New Delhi
Summary
Healthcare executive specializing in pharmacovigilance and ICSR processing. Track record of optimizing patient support programs and quality assurance processes, ensuring regulatory compliance and improving patient care standards. Acknowledged for analytical capabilities and innovative problem-solving in dynamic environments, producing significant results.
Overview
2
2
years of professional experience
4
4
Certifications
Work History
Jr. Pharmacovigilance Associate
AllMS
New Delhi
10.2025 - Current
- Managed ICSR handling including data entry, medical review, coding, and timely submission to meet PVPI requirements.
- Maintained 100% compliance with PVPI timelines and SOP standards throughout all processes.
- Ensured completeness, accuracy, and regulatory compliance of all safety reports submitted.
- Drafted structured case narratives and conducted QC validation to ensure over 98% accuracy.
- Performed WHO-UMC causality assessments to analyze event relationships effectively.
- Coordinated follow-ups with healthcare professionals to efficiently gather missing case information.
- Supported literature screening and signal detection activities to proactively identify potential safety concerns.
Executive (Program Management)
Tata 1mg Technologies
Gurgaon
01.2025 - 05.2025
- Managed safety case narrations and adverse event reporting in AERO Safety Database, ensuring data integrity and adherence to regulatory standards.
- Reviewed 10 percent of day-minus-one reported safety cases daily, identifying deviations to facilitate timely corrective actions.
- Reported unplanned deviations to relevant stakeholders for immediate corrective action.
- Conducted source data quality checks, validating accuracy and completeness of documents to support compliance and reporting.
Executive (Institutional QA)
Tata 1mg Technologies
Gurgaon
10.2023 - 01.2025
- Executed quality audits on 100 SKU web pages, improving content accuracy and ensuring regulatory compliance.
- Conducted comprehensive audits ensuring RCA and CAPA compliance, supporting operational excellence.
- Performed virtual audits on AE tracker reports, verifying accuracy and completeness to uphold quality standards.
Education
Masters of Pharmacy - Pharmacy Practice
School Of Pharmaceutical Education And Research (SPER)
New Delhi01.2023
Bachelor Of Pharmacy -
Shri G.S. Institute of Technology And Science
Indore, M.P01.2021
Skills
- ICSR oversight
- Causality assessment
- Reporting adverse events
- Narration of safety cases
- Scientific literature review
- Drug labeling review
- Audit and CAPA management
- Quality management systems
- SOP development and review
- Verification of source data accuracy
- Management of product quality complaints
- Proficient in MS Office tools (Excel, Word, PowerPoint)
- Use of Mendeley and Zotero for references
Certification
Microsoft Excel - Advanced Skills Certification, Tata 1mg, 2025.
Accomplishments
Qualified GPAT, 2021.
Conference Abstract
- Co-author of two abstracts for ISQua's 42nd International Conference, 2026 (Dublin, Ireland), focusing on the detection of drug safety signals using FAERS OpenVigil through disproportionality analysis.
Languages
- English
- Hindi
Platforms Worked
ADRMS | Vigiflow | AERO | CRM | Kapture | Jira | CS Console | QMS (MedQpro) | Zotero | Mendeley | Clinicaltrials.gov | Pubmed
Timeline
Jr. Pharmacovigilance Associate
AllMS
10.2025 - Current
Executive (Program Management)
Tata 1mg Technologies
01.2025 - 05.2025
Executive (Institutional QA)
Tata 1mg Technologies
10.2023 - 01.2025
Masters of Pharmacy - Pharmacy Practice
School Of Pharmaceutical Education And Research (SPER)
Bachelor Of Pharmacy -
Shri G.S. Institute of Technology And Science