Hemamalini Balaganesan
Medical device vigilance| Pharmacovigilance specialist| Literature reviewer| Quality reviewer| ICSR | LSMV| ArisG | Veeva safe | pharmacist|
- Role
- Pv Scientist Ii at Tata Consultancy Services
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Hemamalini Balaganesan
Meticulous and performance-driven Pharmacovigilance and Medical Device Vigilance Quality Reviewer with 6+ years of global drug safety experience across end-to-end case processing, quality review, literature assessment and medical device vigilance. Proficient in ICSR/SUSAR review, MedDRA/WHO Drug coding, CAPA validation, and audit readiness under EU MDR 2017/745, FDA 21 CFR Part 803, GVP, and ICH E2B(R3). Adept at managing large-scale safety data migrations, quality compliance activities, and cross-functional collaborations to achieve operational excellence. Recognized for maintaining >99% case quality accuracy, implementing process improvements, and mentoring teams to consistently exceed compliance goals.
Experience
Pv Scientist Ii
Jun 2024 — Present · Bengaluru, IN
Education
Jkk Munirajah Medical research foundation college of Pharmacy Erode city Tamilnadu
Master of pharmacy, Pharmacy, Pharmaceutical Sciences, and Administration
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