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Kavya M. — Mid-Level Pharmacovigilance Officer from India

Kavya M.

Mid-Level Pharmacovigilance Officer

India 2-3 years
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About

Kavya M. is a proficient Pharmacovigilance Officer at Hetero Labs Limited in Hyderabad, specializing in quality oversight within Clinical Development and Medical Affairs. Since September 2023, she has successfully developed training plans for over 50 team members, leading to a 25% reduction in onboarding time. Kavya expertly manages CAPA and deviation handling, contributing to a 15% improvement in audit readiness scores, while supporting internal and two external audits and regulatory inspections with no critical findings. She excels in conducting capability assessments for vendors and leads the qualification process for new partners. Additionally, she negotiates and maintains over 90 global PVAs, ensuring full compliance with pharmacovigilance regulations. Her technical skills include processing 400+ ICSRs with 98% accuracy and handling E2B conversions using Argus Safety. Kavya's academic background features a Master of Pharmacy in Pharmacology, supporting her role in enhancing operational excellence and patient safety.

Experience

  • Pharmacovigilance Officer

    Hetero Labs Limited · 2023 — Present
    Implemented training plans impacting over 50 team members to enhance onboarding efficiency. Managed CAPA and deviations, contributing to improvements in audit readiness. Assisted in both internal and external audits and regulatory inspections with no critical findings. Conducted vendor capability assessments and led the qualification process for new partnerships. Negotiated and upheld over 90 global PVAs, ensuring compliance with current pharmacovigilance regulations. Educated more than 45 affiliate safety representatives on local PVA implementation. Processed more than 400 ICSR cases with high accuracy, including the E2B conversion and processing utilizing Argus Safety. Contributed to various safety reports by ensuring timely and accurate data handling.

Skills & Expertise

Education

  • Master of Pharmacy in Pharmacology
    Vignan Institute of Pharmaceutical Technology · 2021 — 2023
  • Bachelor of Pharmacy
    Malineni Perumallu Educational Society Group of Institution · 2017 — 2021

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