Sneha Kulkarni
Pharmacovigilance Associate (Drug Safety)
sneha.kulkarni@example.com · +91 77XXX XXX31 · Mysuru, Karnataka · linkedin.com/in/sneha-kulkarni-example
Summary
Pharmacovigilance associate with 2 years of experience in end-to-end ICSR case processing for spontaneous, literature and clinical trial cases. Skilled in Oracle Argus Safety, MedDRA coding, causality and seriousness assessment and narrative writing, with 98% quality scores and zero late submissions.
Skills
- ICSR case processing
- Oracle Argus Safety
- MedDRA coding
- WHO Drug Dictionary
- Narrative writing
- Seriousness and causality assessment
- Literature screening
- E2B (R3) basics
Core skills
Medical writing · Attention to detail · Regulatory timelines · Quality focus · Teamwork
Work experience
Drug Safety Associate, Vigilex Drug Safety Services Pvt Ltd, Mysuru
Sep 2024 – Present
- Process 7–9 ICSRs a day end to end in Argus Safety, covering triage, data entry, MedDRA and WHO-DD coding, and narrative writing.
- Assess seriousness, expectedness against the reference safety information and reporter causality for spontaneous and post-marketing cases.
- Maintain a 98.2% first-pass quality score over 12 months and met every 15-day and 7-day expedited reporting timeline.
- Draft follow-up queries to reporters, increasing complete-case rate for a key product by 20%.
Pharmacovigilance Trainee, Kaveri Pharmaceutical Research Pvt Ltd, Bengaluru
Jan 2024 – Aug 2024
- Screened 250+ literature articles a month for adverse event reports on 6 marketed molecules.
- Performed duplicate checks and case booking for incoming email and call-centre reports.
- Supported reconciliation between the safety database and the medical information log.
Education
Pharm.D, Doctor of Pharmacy
2017 – 2023
College of Pharmacy, Mysuru · 8.4 CGPA
Certifications
- Certificate course in pharmacovigilance and drug safety, Professional training institute, Oct 2023
Languages
English (Fluent) · Kannada (Native) · Marathi (Fluent) · Hindi (Conversational)