MD, Pharmacovigilance certification

Diwanshu Sharma,

MD

Burlington, North Carolina *7215, Tel: 336-***-****,

******************@*****.***

OBJECTIVE

More than 5 years of experience in the healthcare industry both in the clinical aspect as well as medical research.

Proven experience with data entry, preparation of Safety reports (DSUR),use of MedDRA and medical terminology. Experience with multiple fields of medicine, including oncology, physiology, ENT, pain management, pathology and pharmacology. Multi-tasker, detail-oriented and team player with excellent interpersonal skills. Effectively communicates with medical personnel, colleagues, and patients. Knowledge of Argus database

EDUCATION

Advanced International Pharmacovigilance and Argus Safety Certification (APVASC) 05/2022 CCRPS

Patient Safety and Quality Improvement: Developing a Systems View (Patient Safety) 04/2022 John Hopkins University

Clinical Research Professional Certification 11/2018 Massachusetts

M.D./Residency, Pharmacology 01/2012 – 05/2015

Maharishi Markendeshwar Institute Of Medical Science and Research, Haryana, India Doctor of Medicine 08/2004 – 10/2010

Acharya Shri Chander College Of Medical Sciences, India EXPERIENCE

Internal Medicine Physician

02/2018 – 01/2022

Icliniq (virtual )

Provided patient diagnosis, test evaluation and treatment under strict time constraints; Medical review of cases,sent out prescriptions to pharmacies through the electronic medical records system; provided education on whatever disease the patient is suffering from; explained results to patients. Clinical Research Scholar

11/2018 – 03/2019

Axilogy Consultants LLC, Boston, Massachusetts

Knowledge of ICH and GCP regulations. Quality monitoring, regulatory training, audits and inspections Evaluate and process Expected Adverse Event (EAE) reports received from clinical sites including preparation of Safety Reports (DSUR,PBRER)and regulatory guidelines; collecting accurate information from the site; independent chronologically, well thought out, and detailed case narratives; Assisted for the Institutional Review Board submissions and other regulatory forms; Knowledge of MedDRA; signal detection;accurately completed and maintained case report forms; Use of Argus database; conducted medical review of individual case safety reports; evaluated safety signals Assistant Professor/Pharmacovigilance Assistant

08/2017 – 01/2018

Department of Pharmacology, Acharya Shri Chander College of Medical Sciences And Hospital, India

Filled drug reaction forms and completed safety reviews; Summarized aggregate data and detailed safety reviews; Attended faculty meetings and participated in student outcome assessments with departmental members; Researched and wrote articles on drugs effects on body, in professional journals and publications. Medical review of cases

Senior Resident

07/2015 – 07/2017

Department of Pharmacology Acharya Shri Chander College of Medical Sciences, India Prescribed medications, explaining side effects and possible adverse reactions to keep patients informed; Did drug side effect monitoring; Wrote articles related to drug effects; Prescribed medications; took lectures of undergraduate medical students

Junior Resident

03/2011 – 04/2012

Department of Pharmacology, Acharya Shri Chander College of Medical Sciences And Hospital, India

Conducted pharmacy lab experiments; Taught undergraduate medical students through presentations; Conducted nursing and dentistry classes.

CERTIFICATION & SKILLS

• Advanced International Pharmacovigilance and Argus Safety

• Patient Safety and Quality Improvement: Developing a Systems View

• Knowledge of Good Clinical Practice (GCP) • Knowledge of US and International regulatory Requirements • Computer skills (MS word/excel) • Pharmacovigilance • Leadership • Successful problem solver • Advanced knowledge of medical terminology • Extreme attention to detail

• Great work ethic

• Excellent time management, multitasking and organizational skills • Team player

• Excellent verbal and written communication skills • Medical review LANGUAGE PROFICIENCY

I am fluent in the following languages:

English

Hindi

Urdu

Dogri

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