Prabhat Kumar Vishwakarma
Sidhi
Summary
Experienced Senior Drug Safety Associate specializing in pharmacovigilance and ICSR preparation. Track record of mentoring and training that boosts trainee quality scores through effective feedback. Strong skills in data analytics and team collaboration, driving compliance with regulatory standards and optimizing operational processes.
Overview
11
11
years of professional experience
Work History
Senior Drug Safety Associate (Literature Case)
Qinecsa Solutions
Mysore
05.2021 - Current
- Delivered structured classroom and on-the-job training to new hires on pharmacovigilance processes, SOPs, and regulatory requirements.
- Designed and executed training plans to support smooth onboarding and transition to independent productivity.
- Mentored associates during live case processing, providing real-time guidance and corrective feedback.
- Conducted assessments, knowledge checks, and refresher sessions to evaluate trainee readiness and identify gaps.
- Tracked trainee performance through quality and productivity metrics; documented progress and created improvement plans.
- Partnered with quality and operations teams to address recurring errors through targeted retraining.
- Acted as a subject matter resource for trainees and team members on process and compliance queries.
- Collaborated with global stakeholders to align training delivery with project timelines and expectations.
- Supported QC and sampling activities, ensuring adherence to SOPs and regulatory standards.
- Performed peer reviews and provided structured feedback to improve case quality.
- Contributed to audit and inspection readiness by maintaining consistent training documentation and compliance support.
- Successfully trained and onboarded three batches (new hires), reducing time to independent productivity.
- Improved trainee quality scores through focused coaching and retraining interventions.
- Strengthened training consistency by reinforcing SOP adherence and best practices.
Pharmacovigilance Analyst (ICSR)
Wipro
Delhi
01.2019 - 05.2021
- Prepared, reviewed, and verified Individual Case Safety Reports (ICSRs) to ensure compliance with global pharmacovigilance requirements, enhancing data integrity.
- Ensured accuracy and consistency of adverse event (AE) forms, submitting Regulatory Safety Information (RSI) reports to the Drug Safety Unit (DSU) within defined timelines to maintain regulatory standards.
- Analyzed structured and unstructured source data to accurately classify RSI versus non-RSI cases, improving case management efficiency.
- Performed peer reviews and provided mentoring and on-the-job support to new team members to improve quality and compliance.
- Contributed to the development, review, and updates of SOPs and work instructions to support process standardization and training effectiveness.
Junior Research Fellow (SERB-DST Project)
Guru Ghasidas Central University
Bilaspur
12.2017 - 01.2019
- Mentored and supervised students in experimental research, promoting ethical standards and rigorous study protocols to enhance research integrity.
- Delivered hands-on training in pharmacological screening and stereotaxic brain implantation in rodent models, contributing to improved understanding of biological drug evaluation techniques.
- Trained students in scientific literature search strategies using databases like PubMed and ScienceDirect, facilitating effective research methodologies.
Senior Research Fellow (AYUSH-EMR Project)
Guru Ghasidas Central University
Bilaspur
11.2015 - 12.2017
- Trained and guided students in isolating plant-based active ingredients and conducting pharmacological screening, enhancing research compliance with established protocols.
- Mentored students in experimental research activities, ensuring adherence to study protocols, ethical standards, and accurate documentation.
- Facilitated scientific literature searches and evidence retrieval using research databases, supporting informed decision-making in research initiatives.
Assistant Professor (Pharmacology)
Shri Rawatpura Institute of Pharmacy
Raipur
11.2014 - 11.2015
- Managed animal house operations and supervised final-year pharmacy research projects, ensuring adherence to institutional, ethical, and regulatory standards.
- Supervised and evaluated final-year undergraduate research projects, focusing on research methodology, data interpretation, and scientific reporting.
- Tutored Diploma and Bachelor of Pharmacy (B. Pharm) students in core pharmacy subjects, enhancing academic understanding and performance.
Education
Master of Pharmacy (M. Pharm) - Pharmacology
Guru Ghasidas Central University
Bilaspur06-2014
Bachelor of Pharmacy (B. Pharm) - Bhopal
Barkatullah Vishwavidyalaya
Bhopal06-2012
Diploma in Pharmacy (D. Pharm) - Bhopal
VNS Institute of Pharmacy
Bhopal06-2009
Senior Secondary (10+2) - Sidhi
Saraswati Higher Secondary School
Sidhi06-2006
High School (10th) - Sidhi
Gandhi Vidyalaya High School
Sidhi06-2004
Skills
- Pharmacovigilance expertise
- Safety operations management
- ICSR preparation and review
- Literature case analysis
- Quality control (QC) processes
- Database management for safety reporting
- Proficient in Argus and PVA tools
- Spotfire data visualization skills
- Medical coding with MedDRA standards
- WHO-DD adherence practices
- Narrative writing for safety reports
- Mentoring and training delivery
- Compliance development strategies
- Knowledge transfer sessions
- Feedback on performance reviews
- Scientific research and analysis skills
- Data analytics and observation techniques
- Proficient in MS Office Suite applications
- Effective mailbox management strategies
- ICSR reporting
- Attention to detail
- Team collaboration
- Critical thinking
- Multitasking capacity
- Problem-solving capacity
Awards
- Registered Pharmacist, Madhya Pradesh State Pharmacy Council (PCI).
- Received Appreciation Letter from Wipro Management for performance and contributions, 2019.
- Qualified Graduate Pharmacy Aptitude Test (GPAT), 2012 (All India Rank: 2393).
- Presented a scientific poster at the 46th Indian Pharmaceutical Society (IPS) Conference, 2013.
Publications
- Charota (Cassia tora) Gum: A Potential Element as Suspending Agent – An Investigation of Suitability for Development of Paracetamol Suspension., Indo-Global Research Journal of Pharmacy, 2022
- Central Histaminergic Transmission Modulates the Expression of Chronic Nicotine Withdrawal–Induced Anxiety-Like and Somatic Behavior in Mice., Behavioural Brain Research, 2021
- Drugs and Chemicals Tragedy., CSVTU International Journal of Biological and Biomedical Sciences, 2019
- Magnesium Taurate Attenuates Progression of Hypertension and Cardiotoxicity Against Cadmium Chloride–Induced Hypertensive Albino Rats., Journal of Traditional and Complementary Medicine, 2018
- An Ayurvedic Formulation “Sankat Mochan”: A Potent Anthelmintic Medicine., Journal of Drug Delivery and Therapeutics, 2017
- Protective Effect of Alpha-Lipoic Acid on Progression of Cataract Formation in Fructose-Induced Experimental Cataract., PharmaNutrition, 2017
Disclaimer
I hereby declare that the information furnished above is true and correct to the best of my knowledge and belief, and I take full responsibility for the accuracy of the details provided
Book Contribution
Chhattisgarh: A Natural Diversified State of India, Lambert Academic Publishing, 2019, Co-author
Tools And Systems
- Safety Databases: Argus / ARISg / Safety Easy (customize)
- MedDRA
- WHO-DD
- MS Excel, Word, PowerPoint
Timeline
Senior Drug Safety Associate (Literature Case)
Qinecsa Solutions
05.2021 - Current
Pharmacovigilance Analyst (ICSR)
Wipro
01.2019 - 05.2021
Junior Research Fellow (SERB-DST Project)
Guru Ghasidas Central University
12.2017 - 01.2019
Senior Research Fellow (AYUSH-EMR Project)
Guru Ghasidas Central University
11.2015 - 12.2017
Assistant Professor (Pharmacology)
Shri Rawatpura Institute of Pharmacy
11.2014 - 11.2015
Master of Pharmacy (M. Pharm) - Pharmacology
Guru Ghasidas Central University
Bachelor of Pharmacy (B. Pharm) - Bhopal
Barkatullah Vishwavidyalaya
Diploma in Pharmacy (D. Pharm) - Bhopal
VNS Institute of Pharmacy
Senior Secondary (10+2) - Sidhi
Saraswati Higher Secondary School
High School (10th) - Sidhi
Gandhi Vidyalaya High School