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
Manufacturing & ProductionView LinkedIn profile

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

  1. Pv Specialist

    Dr. Reddy's Laboratories

    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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Kalyani R. — Pv Specialist at Dr. Reddy's Laboratories in Hyderabad, TG, IN | Unifers