G V Ramana
Summary
Pharmacovigilance Professional with over 8 years of experience in managing adverse events from diverse sources, including literature, clinical trials (CT), patient support programs (PSPs), spontaneous reports, and pregnancy-related cases. Adept at ensuring the safety and efficacy of pharmaceutical products through comprehensive analysis, risk management, and regulatory compliance.
Overview
8
8
years of professional experience
Work History
Associate Manager
Elanco IAC
Bangalore
02.2022 - Current
- ICSRs: Performed triage, data entry, and quality review of Individual Case Safety Reports (ICSRs) for all types of cases, including spontaneous reports, clinical trials, literature, patient support programs, etc., to ensure data accuracy, completeness, and compliance with regulatory standards.
- Deviation and CAPA Handling: Managed deviations in ICSR processing and implemented Corrective and Preventive Actions (CAPA) to ensure compliance with global pharmacovigilance regulations and enhance process efficiency
- Team Communication and Updates: Effectively communicated process changes and updates to team members, ensuring alignment and smooth workflow in compliance with pharmacovigilance activities
- Case Allocation and Prioritization: Accountable for allocating cases and managing employee workload based on priority, seriousness, and case types to ensure timely regulatory compliance and efficient distribution, avoiding missed timelines
- Training and Mentorship: Trained and onboarded new associates on case handling, providing continuous guidance until they were fully proficient in case processing
- Participated in pharmacovigilance audits and inspections, ensuring compliance with FDA, EMA, and ICH-GCP guidelines
- Supported the development of standard operating procedures (SOPs) and training materials for pharmacovigilance processes
- Possess in-depth knowledge of pharmacovigilance guidelines and regulations, including ICH, FDA, EMA, 21 CFR, and GVP ensuring compliance and patient safety
Senior Pharmacovigilance Associate
Apcer Life Sciences Pvt Ltd
Ahmadabad
07.2019 - 08.2021
Senior Drug Safety Associate
Bioclinica India Pvt Ltd
Mysore
11.2016 - 05.2019
Education
M. Pharmacy -
Andhra University
Visakhapatnam, Andhra Pradesh01.2015
B. Pharmacy -
AVNP (JNTU-K)
Andhra Pradesh01.2013
Skills
- ARGUS
- MedDRA coding
- Quality compliance
- Good Pharmacovigilance Practice (GVP)
- Good Clinical Practice (GCP)
- Veeva Vault
Timeline
Associate Manager
Elanco IAC
02.2022 - Current
Senior Pharmacovigilance Associate
Apcer Life Sciences Pvt Ltd
07.2019 - 08.2021
Senior Drug Safety Associate
Bioclinica India Pvt Ltd
11.2016 - 05.2019
M. Pharmacy -
Andhra University
B. Pharmacy -
AVNP (JNTU-K)
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