Professional Summary

Seasoned Medical Professional (MBBS, MD) with 4+ years of Experience in Pharmacovigilance/Drug Safety and 3+ years of Patient Care experience

Expert in Medical Assessment of Individual Case Safety Reports, Signal Detection, Labelling, MedDRA Coding

Well versed in ICH-GCP Guidelines, FDA Regulatory Affairs

3+ years of Patient Care experience –1.7 years as Resident Medical Doctor in private hospitals, 1 year at government hospital (Residency), 1.5 year of private practice

Work Experience

Associate Medical Safety Advisor, Quintiles Research India, Dec 2015-Nov 2016; Client: Fortune 500 Company; Department: Life Cycle Safety

-Played a pivotal role in the overall pharmacovigilance process and provided medical expertise in the evaluation of drug safety data (medical review of Individual Case Safety Reports) from a variety of sources including serious & expedited reports and pregnancy reports

-Demonstrated active medical leadership in the implementation and execution of an improved labelling and causality assessment procedure (was rewarded with “Bravo” for this)

-Acted as the primary pharmacovigilance physician (joint) for drug Ustekinumab in conjunction with the Safety Surveillance Group and was responsible for evaluating weekly Watch list & DME line-listings and labelling issues

-Collaborated with multiple teams - operations, quality review, oversight SSP - to ensure timely reporting of safety data of biologic drugs to Regulatory Authorities

-Was instrumental in signal detection efforts by execution of pharmacovigilance components of Risk Management Programs and related activities including assessment of potential signals

-As a part of MedDRA coding participated in selection of appropriate Reported Reaction Term (RRT) which would match with the Preferred Term (PT), while conveying the medical concept

-Trained Case processors on labelling and de/re challenge

-Extensive knowledge and experience in data mining, ICH-GCP guidelines, literature review

-Work experience in SCEPTRE database

Resident Pharmacovigilance Physician, June, 2012- October, 2015

I was involved in the National Pharmacovigilance Programme of India by way of collection, entry of information into Vigiflow (WHO database), causality and seriousness assessment of adverse drug reactions. I did complete medical assessment of cases followed by reporting to WHO.

Resident medical officer in Park Neurosurgery Nursing Home Kolkata, 2008-2009

- Acted as an active physician and assisted in various neurosurgical emergencies

Intern under Dr. A. G. Ghoshal, A famous Pulmonologist in Kolkata, 2008-2009

-As a physician, examined patients, made provisional diagnosis and prescribed medications

Resident medical officer in the Department of Medicine, Peerless Hospital, Kolkata, March, 2008-August, 2008

-Acted as the on premise doctor responsible for patients including emergencies

Private Practice (General Physician) – Kolkata, India, 2007-2008

Medical Internship (Residency) – Thanjavur Medical College Hospital, 2005-2006

Publications/Presentations

Authored article titled “Quantitative and Qualitative analysis of prescriptions at a tertiary health care hospital” published in Journal “Drug and Therapy Perspectives”

Presented oral paper on “Usage of antimicrobial prophylaxis for major surgical procedures in gynaecology and obstetrics” organized by Indian Pharmacological Society, at National Institute of Mental Health and Neuroscience, Bangalore, Karnataka, from 16th – 18th December, 2013

Presented poster on “A study of the drug use pattern in different medical specialties using WHO prescribing indicators” at CME on “System, Monitoring in Critical Care” held at Ahmedabad on 21st Sep, 2014

Conferences/Workshops

Attended PHARMATECH- 2015, Mumbai, Theme : "Frontiers in Pharmacology" which included Pre-clinical Research, Clinical Research and Specialty Domains in Pharmacology

Attended Annual Conference of the Indian Pharmacological Society (IPSCON), Bangalore 2013. Topic: “Translating Research to Therapeutics" which included pharmacogenomics and personalized medicine, drug discovery current developments, advanced pharmacology of lifestyle diseases

Attended CME on “System, Monitoring in Critical Care” on 21st Sep, 2014 organized by AMCMET Medical College, LG Hospital Campus, Ahmedabad

Research

Conducted extensive research and submitted dissertation on “A Study of Chemoprophylaxis in patients undergoing major surgical and Gynaecological procedures” that included preparation of the protocol, data collection, analysis and presentation

Academic Experience

Participated in the National Pharmacovigilance Programme of India by way of collection, reporting and analysis of adverse drug reactions to the National Coordinating Centre and its entry in the VigiFlow software along with medical assessment of the report, as recommended by the WHO

Was instrumental in conducting seminars regarding aggregate reporting, namely PSURs, PADER, PBRER

Conducted both in vivo (tests on analgesic, antidepressant, antiepileptic activity) and in vitro experiments (bioassays)

Conducted Clinical pharmacology exercises (preparation of protocol of clinical trials, informed consent form and case based learning from actual clinical cases)

Participated in bioavailability/bioequivalence studies in a CRO

Presented seminars and conducted training programs for other residents on ICH-GCP guidelines

Education

M.D. PHARMACOLOGY

B.J. Medical College, Ahmedabad, India

(Gujarat University)

2012- 2015

M.B.B.S.

Thanjavur Medical College, Tamil Nadu, India

(Dr. M. G. R. Medical University)

2000-2005

(Internship 2005-2006)

HIGHER SECONDARY

Central Hindu Girl’s School, Varanasi, India

(Central Board of Secondary Education)

1996-1998

References

1.Dr. Anita Singh, Manager, Pharmacovigilance, Bangalore, India

2.Dr. R.K Dikshit, HOD, Department of Pharmacology, GMC, Ahmedabad, India

3.Dr K Gomathi, Professor, Department of Obstetrics and Gynaecology, Thanjavur Medical College, Tamilnadu, India

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