Dr. Nisheeth Kumar has over 15 years of experience in clinical practice and drug safety. He received his M.B.B.S. from Seth GS Medical College & KEM Hospital Mumbai in 2004. Since 2013, he has worked as a Drug Safety Physician and Senior Drug Safety Physician at Quantum Solutions India, where he performs medical review and ensures drug safety. He is proficient in medical terminology and pharmacovigilance guidelines. Prior to his current role, he practiced clinically for 8 years and also participated in public health initiatives with WHO and Doctors For You.

1. NAME: DR. NISHEETH KUMAR
QUALIFICATION : M.B.B.S. FROM SETH GS MEDICAL COLLEGE & KEM
HOSPITAL MUMBAI (GRADUATED IN 2004)
DATE OF BIRTH: 11/02/1979
CAREER SUMMARY
2005-2012: CLINICAL PRACTICE
01/2013-03/2014: DRUG SAFETY PHYSICIAN (PHARMACOVIGILAN CE)
QUANTUM SOLUTIONS INDIA
04/2014-TO DATE: SENIOR DRUG SAFETY PHYSICIAN (PHARMACOVIGILAN CE )
QUANTUM SOLUTIONS INDIA
MARITAL STATUS: MARRIED
CURRENT LOCATION: CHANDIGARH
LOCATION PREFERENCE: ANYWHERE IS FINE
EMAIL ID: dr.nisheeth@gmail.com
Phone No.: 08699347210
PROFESSIONAL KNOWLEDGE/EXPERIENCE

2. Drug Safety Experience
 Expertise in performing medical review of literature publications and
abstracts for the purpose of potential safety signal.
 Ensuring the quality, accuracy, timely review, overall medical
assessment and validity/invalidity of literature reports.
 Expertise in performing medical review of CSR SAE narratives.
 Expertise in providing medical inputs and advice to
pharmacovigilance scientists on medical aspects in processing of
Individual Case Safety Reports (ICSRs).
 Expertise in performing single case medical review in the safety
database.
 Provide medical inputs during triage, assessing events for coding and
MEdDRA coding of events and query handling.
 Trained in handling Enterprise Resource Planning (ERP) tool.
 Maintaining a good knowledge of the Adverse Events (AE) safety
profile of assigned drugs/class of drugs, Reference Safety
Information documents, data entry conventions and guidelines,
aggregate reporting conventions and guidelines, client’s procedures
and international drug safety regulations including ICH Guidelines,
GVP guidelines, Volume 9A, FDA Guidelines, CIOMS , GCP etc.
 Maintaining an awareness of global regulatory reporting obligations
and organizing workload to ensure compliance with regulatory
timelines.
 Maintaining a good knowledge of Medical Terminology and MedDra
coding in accordance with “MedDRA term selection: Points to
consider”.
 Trained in performing medical review of clinical overviews.

3.  Trained in aggregate safety data reports including Periodic Benefit
Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports
(PSURs) and Addendum to Clinical Overview (ACOs).
 Provide training and mentoring of internal and cross-functional team
members.
 Interact with internal and external contacts to resolve issues related
to medical review.
Clinical Experience
 Around 8 years of clinical practice experience ranging from working
in one of the most prestigious tertiary hospitals in India in KEM
Hospital Mumbai, to working as Surveillance Monitor in Pulse Polio
Programme with WHO, working on disaster relief initiatives with
Doctors For You (DFY) and Private clinical practice.
Computer Skills
Proficient in computer operating systems, MS Office, Internet, E -Mail.
Soft Skills
An analytical bent of mind and positive attitude and strong attention to
detail.
A skilled communicator with very good interpersonal abilities.
A Keen Strategist with good intellect and problem solving skills.
Other Key Achievements
 Scored 99.71 percentile in CAT conducted by IIMs.
 Secured All India Merit Rank 222 in All India Pre-Medical entrance
test conducted by CBSE amongst lakhs of entrants to secure

4. admission in one of the most premier medical colleges in India Seth
GS Medical College and KEM Hospital Mumbai.
Seminars/Conferences Attended
 Annual conference on Pharmacovigilance of SOPI held at NMCH Patna
in November 2011.
 Max CME Series 2006 CME on Infectious Diseases Update at Marriott
Welcomgroup Hotel New Delhi.
 NESCON 2005: 13TH National Conference on New Emerging Scenarios
in HIV, T.B., Respiratory & Environmental Diseases at Taj Lands End
Mumbai.