DR - Rajan - CV - 23-May - 2023

RESUME
Dr. Rajan Sharma

Mobile: 09768730301
E-Mail: rajan498@rediffmail.com
Professional Summary
I have a total of twenty-eight years of experience.Eleven years as medical officer in Primary

Health Centre, seven years as Principal investigator in Bio- Equivalence studies, and seven years
as Medical Reviewer in (ICSR) Pharmacovigilance. I am Looking for an opportunity where I can
share my experience and use my expertise in the field.
Educational Qualifications
• MBA -Healthcare services from Sikkim Manipal University in the year 2014.
• PGDM-Project Management from Sikkim Manipal University in the year 2015.
• Post Graduate Certificate Course in Pharmacovigilance from Maharashtra University
of health Sciences, Nashik, March 2009.
• Post Graduate Certificate Course in Clinical Research and Clinical Data Management
from Pune University, May 2006.
• Post Graduate Certificate Course in Clinical Research and Trials Management from
ICRI Mumbai, June 2005.
• MBBS from Sambhalpur University, Odisha (Registration number MMC-75202)
• Valid registration MMC-75202 up to September 2026.
Work Experience
• Principal Investigator at Vergo Clinicals, Goa July2019 to May 2023.

• Sr. Medical Reviewer with Bioclinica, Mysore, Karnataka from February 2019 to June
2019.
• Sciformix Technology Pvt Ltd from February 2018 to November 2018.
• Tata Consultancy Services (TCS), Mumbai in Pharmacovigilance from May 2012 to
February 2018.
• Ashco Niulab Industries Ltd. Andheri, Mumbai as Asst. Manager Principal investigator
and Clinical investigator from May 2011 to May 2012.
• Principal Investigator with Macleods Pharmaceutical Ltd. Andheri, Mumbai from
February 2009 to May 2011.
• Clinical Research Physician in Mayfair Clinical Education and Research Centre, Thane,
Mumbai from 2007 to 2008.
• Medical officer in Government of Maharashtra Health Services in Raigad Zilla Parishad,
Alibaug, from March 1995 to 2007.
Job Profile
Clinical Research Organization (CRO)

• Overall responsibility for supervising the clinical study related activities.
• Providing input in protocol and informed consent for dosing information, contra
indications, warnings, precautions, adverse events and detailed description of trial related
activities.
• Providing inputs in REMS (Risk evaluation mitigation strategy).
• Training to staff personnel in trial related duties, prior to performing any study and
ensuring adequate facility and resources are available for proper conduct of study.
• Ensuring timely reporting for deviation, premature termination of study, serious adverse
events and to provide adequate medical management and review on serious adverse
events reports.
• Also responsible for accountability of investigational product from time of receipt till the
retention and archival of drugs.
• Conduction of Clinical Phase of BA/BE study as per ICH-GCP guidelines and even
conducted study for US-FDA, EMEA, WHO.
• Screening of volunteers for BA/BE study and screening of hematology, biochemistry,
serology and urine report for the study.
• Evaluation of serious adverse drug reactions (causality assessment), safety report filling,
ECG evaluation during screening and post study safety assessment.
Pharmacovigilance - Tata Consultancy Services (TCS)
• Performing case analysis and peer review. Reviewing spontaneous, clinical, NIS, NIP
cases.
• Verifying coding, labeling, Narrative reviewing, causality assessment and follow up.
• Accountable for the medical review of relevant clinical and spontaneous cases (including
literature articles), medical assessment (including causality) and overall cohesiveness of
individual case safety reports for a particular product or group of products on a national,
regional, or global basis in line with regulatory and SOP requirements.
• Accountable for the final medical review of ICSRs including decisions on potential
SUSARs in a timely fashion and ensuring that all necessary queries have been addressed.
• Notifying of any potential SUSARs identified.
• Responsible for generating, sending, and tracking data queries, together with other PDSO
staff, to Affiliates, SAE responsible and regional centers.
• Responsible for developing close links and communication with relevant Safety
Operations Physicians groups maintaining awareness of critical AEs / and other issues for
assigned product(s).
• Conducting/ supporting individual case safety data entry assessment and medical review
according to SOPs and guidelines.
• Supporting the Drug Safety teams with medical concepts and awareness of product
related topics to ensure quality of adverse event data processing.
• Assuring and maintaining compliance with regulatory and local/global SOP
• Ensuring opportunities are identified and communicated to streamline AE processing.
Medical Officer - Primary Health Centre (PHC)
• IPD & OPD and referral services.

• Implementation of National Program in PHC jurisdiction through supervisors and health
workers.
• Conducting Postmortem and handling Medico legal cases.
• Supervision of overall PHC.
• Conducing training programs for health workers.
Training and Conferences
• Workshop on ‘ECG interpretation’ – DMRC (Desai Medical and Research Centre), Goa’.
• Workshop on ‘Advance Cardiac Life Support (ACLS)’ – DMRC, Goa.
• Training on ‘Community Based Rehabilitation’ from All India institute of physical
medicine and Rehabilitation, Mahalaxmi, Mumbai.
• Training on ‘Advanced Cardiac Life Support’, Cardiopulmonary cerebral Resuscitation
training Centre, Department of Anesthesiology, Seth G.S. Medical College & KEM
Hospital, Mumbai.
• Seminar on ‘Occupational Health’ organized by IPCL, Nagothane, Mumbai.
Personal Details
.
Permanent Address : A-102, Satyajyot Apartment, Adai, Taluka – Panvel, Navi Mumbai.
Pincode – 410206.
Marital status : Married
Languages : English, Hindi, Marathi, Oriya.
Date: 07/05/2023 Dr. Rajan Sharma

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RESUME

Dr. Rajan Sharma

I have a total of twenty-eight years of experience.Eleven years as medical officer in Primary

• Principal Investigator at Vergo Clinicals, Goa July2019 to May 2023.

Clinical Research Organization (CRO)

Pharmacovigilance - Tata Consultancy Services (TCS)

Medical Officer - Primary Health Centre (PHC)

• IPD & OPD and referral services.

Training and Conferences

Date: 07/05/2023 Dr. Rajan Sharma

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