Pharmacovigilance professional with 3+ years of experience in ICSR case processing. Skilled in literature review, first report searches, quality assessment, and peer training, with a focus on meeting client and regulatory requirements.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Drug Safety Associate
Wipro Limited
02.2022 - Current
Review published reports and biomedical literature to identify and triage individual case safety reports.
Create summary content in various formats, including narrative summaries and E2b records, as part of case processing for regulatory filing.
Conduct local literature monitoring for two individual clients, ensuring compliance with their specific requirements and timely delivery.
Delivered refresher training sessions to the team to maintain and improve internal quality compliance.
Perform quality reviews of individual case safety reports to ensure accuracy and adherence to the information requirements of pharmaceutical clients.
Research Scientist
Actorius Innovation and Research Pvt. Ltd.
04.2021 - 02.2022
Developed a polymer-based novel drug delivery system to enhance the solubility and stability of poorly water-soluble and photo-sensitive drugs.
Collaborated with industry experts and presented a comprehensive Proof of Concept.
Participated in internal and external QMS audits conducted by the British Standards Institution.
Education
Master of Pharmacy -
Dr. Vishwanath Karad MIT World Peace University
10.2020
Bachelor of Pharmacy -
Sinhgad Institute of Pharmacy
06.2018
Skills
MedDRA browser proficiency
Scientific writing
Regulatory and GVP knowledge
Multitasking capacity
Certification
Advanced Program in Regulatory Affairs & Pharmacovigilance from Clini India (2021).
Maharashtra State Pharmacy Council Registration Number- 239158.