1. Vikas Kumar
+91-987-637-2607 J-45, Krishan Vihar,
vikassainidli@gmail.com Delhi, India
Professional Highlights
Passionate pharmacovigilance & drug safety professional with comprehensive experience in
Individual Case Safety Reports (ICSRs) and sound understanding of Pharmacology and
pharmacovigilance.
• Interdepartmental Coordination • Multilevel Project Management
• Proposal Writing • Team Building and Development
Technical Skills Summary
Vigiflow, ICD-10, WHO-ART, WHO - Drug Dictionary, Causality Assessment, Expedited
reporting, ICH guidelines, MedDRA, Narrative writing, Archival of data, Protocol & CRF writing.
Professional Experience
Pharmacovigilance Associate – Indian Pharmacopoeia Commission, India, September
2014 - till date
Receiving ADR reports from reporters through email, fax, post, in person submissions.
Reviewing the cases for seriousness and expectedness, triaging the reports in accordance
with SOP's.
Follow up with the reporter for medical confirmation and incomplete information,
Causality assessment of ADR.
Entry of ADR reports into database by using WHO-ART, ICD-10, WHO drug dictionary
with narrative writing.
Responsible for providing medical and scientific information to health care professionals.
Training/ sensitization/ feedback to physicians through newsletters circulated by the PvPI.
Education and Credentials
Master of Pharmacy (Pharmacology), 2013
Uttarakhand Technical University, Dehradun, Uttarakhand, India
Thesis project: “Prospective observational study of adverse drug reactions of anticancer
drugs used in cancer treatment in a tertiary care hospital” under the guidance of Dr. Yusra
Ahmad.
2. Bachelor of Pharmacy, 2011
Gurukula Kangri Vishwavidyalaya, Hardwar, Uttarakhand, India
Industrial Exposure: Three months summer industrial training in manufacturing of
pharmaceuticals.
Certificates
Certified as Registered Pharmacist (Registration Number: 23349) under Delhi
Pharmacy Council.
Publications
Saini V K, Sewal R K, Ahmad Y, Medhi B. Prospective observational study of adverse
drug reactions of anticancer drugs used in cancer treatment in a tertiary care hospital.
Indian J Pharm Sci 2015;77:687-93.
Rakesh K Sewal, Vikas K Saini, Bikash Medhi. Forensic Pharmacovigilance: Newer
dimension of Pharmacovigilance. J Forensic Leg Med. 2015; 34:113-8.
Conferences Attended
As Speaker
Delivered a Lecture on “Vigiflow & Data Entry” in Preconference Workshop on
Pharmacovigilance in 7
th
National Conference & CME cum Workshop of Indian Society
for Rational Pharmacotherapeutics, PGIMER, Chandigarh on 4
th
December 2015.
Delivered a Lecture on “Vigiflow & Data Entry” in Preconference Workshop on
Pharmacovigilance in 48
th
Annual Conference of Indian Pharmacological Society, PDU
Govt. Medical College, Civil hospital campus, Rajkot, Gujrat on 17
th
December 2015.
Delivered a Lecture on “Vigiflow & Data Entry” in Preconference Workshop on
Pharmacovigilance in 49
th
Annual Conference of Indian Pharmacological Society,
PGIMER, Chandigarh on 20
th
October 2016.
Presentations
Presented a poster “Prospective observational study of adverse drug reactions of anticancer
drugs used in cancer treatment in a tertiary care hospital” in 7
th
National Conference &
CME cum Workshop of Indian Society for Rational Pharmacotherapeutics, PGIMER,
Chandigarh on 4
th
– 6
th
December 2015.
Presented a poster “A study to evaluate the knowledge, attitude and practice of healthcare
professionals for expired drug disposal in northern India.” in 49
th
Annual Conference of
Indian Pharmacological Society, PGIMER, Chandigarh on 23
rd
October 2016.
Participation
Preconference Workshop on WHO ATC/DDD Methodology and Drug Utilization
Research, New Delhi, on 2
nd
- 3
rd
November 2015.
3. Professional Reference
• Dr Yusra Ahmad
Head, Faculty of Pharmacy, Uttarakhand Technical University, Dehradun
Ph: +91-89546-03803, Email: ahmadyusra@gmail.com
• Dr Puneet Dhamija
Assistant Professor, Dept. of Pharmacology, AIIMS, Rishikesh,
Ph: +91-84750-00292, Email: drpdhamija@gmail.com
Dr. Rakesh Sewal
Drug Safety and Surveillance Associate, Janssen-Inc.,
19 Green Belt Drive, Toronto, Canada M3C 1L9,
Tel. 416-382-5000 Ext. 3770, Email: rsewal@its.jnj.com
Declaration
I hereby declare that the above stated information is true to the best of my knowledge and ability.
Place: Chandigarh
(Vikas Kumar)