Kalyani R.
Safety & PV Specialist II/SME /Safety Specialist/Medical Services Analyst/ Junior Data Analyst/Clinical Trial
- Role
- Pv Specialist at Dr. Reddy's Laboratories
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Kalyani R.
Case allocation activities, Subject Matter Expert in resolving critical queries, organization as a mentor, Case processing (ICSR), Handling clinical trial/spontaneous/literature reports, Device Vigilance, literature Screening, Quality Control activities of ICSR, SAE and SUSAR narrative writing, MedDRA coding, Adhoc/CAPA project handling, processing SUSARs, generation of AOSE, AOSE writing, Safety mannagement plan, SAE reconsiliation, Support in DSUR, Scheduling of regulatory reports.• Prepare RCAs and CAPAs on identified SLA deviations during quality checks and facilitate remedial training to mitigate the identified issues, also check the effectiveness of the solutions implemented in the projects.
Experience
Pv Specialist
Sep 2025 — Present · Hyderabad, IN
Education
Dr MGR Educational and Research Institute
B. Pharmacy, Chennai
Sri Padmavati Mahila Viswavidyalayam
Master's degree
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