Ashish Kumar
Bengaluru
Summary
Pharmacovigilance professional experienced in a complete range of industry-related processes, including ICSR processing, medical safety, and document analysis. Proven track record of pharmacovigilance deliverables of the highest quality, and meeting regulatory timelines. Ensure adherence to global pharmacovigilance standards. Strengths lie in understanding of pharmacovigilance protocols and ability to manage multiple tasks. Proven track record in improving efficiency of reporting processes and maintaining high levels of data accuracy.
Overview
4
4
years of professional experience
Work History
Drug Safety Associate- II
Novo Nordisk
08.2023 - Current
- Ensure compliance with global pharmacovigilance regulations which includes FDA.
- Manage safety cases, including case intake/triage, data entry, quality assessment, verification and follow-up activities following the applicable global regulatory requirements.
- Provided trainings, participated in deviation tasks.
- Processed ICSR in various database which include ARGUS, SIMS(Safety Intake Management System) and CC-glow.
- Processed more than 3000 ICSR which includes both serious and non-serious cases received from various source such as spontaneous, patient support program, market research programs.
- Processed United States, China, Canada, Australia and Japan ICSR cases, also followed and submitted serious cases based on US FDA timelines.
- Provided support to New joiners and act as their buddy to get hands on basic pharmacovigilance processes to gain confidence in their working.
- Processed more than 500 ICSR which includes both serious and non-serious cases in Veeva safety.
Project Trainee (Formulation and Development)
SteerLife Private Limited
Bengaluru
08.2022 - 02.2023
- Worked on hot melt extrusion for extended-release formulations.
- Involved in preparation of effervescent tablets and authored Product Development Reports (PDRs).
- Gained exposure to GMP documentation and formulation process optimization.
Education
Masters of Pharmacy - Pharmaceutics
Manipal College of Pharmaceutical Sciences
Manipal, India06-2023
Bachelor of Pharmacy -
Dr. Harisingh Gour University
Sagar, India09-2021
Skills
- Pharmacovigilance & Drug Safety Regulations (FDA, EMA)
- Individual Case Safety Reports (ICSRs) – Veeva safety, Argus, SIMS, CC-Glow
- Strong communication & Quality Oversight
- Problem solving
- Training delivery
- Team Mentorship & Cross-Functional Collaboration
- Strong Communication
- Team Building
- Critical Thinking
Projects
Development of Extended release formulation through hot melt extrusion technique, Steerlife Private Limited, Bengaluru, Karnataka, India, Documentation Required for tablet as GMP.
Hobbies and Interests
- Badminton
- Cooking
- Table Tennis (Intermediate)
Languages
- English
- Hindi
Timeline
Drug Safety Associate- II
Novo Nordisk
08.2023 - Current
Project Trainee (Formulation and Development)
SteerLife Private Limited
08.2022 - 02.2023
Masters of Pharmacy - Pharmaceutics
Manipal College of Pharmaceutical Sciences
Bachelor of Pharmacy -
Dr. Harisingh Gour University