Medical Safety

Shardul Sohani

**** * ***** *** *** B Omaha NE **105

Phone: 804-***-**** Email:*******.******@****.***; *******.******@*****.***

OBJECTIVE

• To be associated with a progressive organization that gives me the scope to apply my knowledge and skills for mutual growth.

KEY SKILLS

Case processing, case receipt, case triage and data entry activities using ARISg and Argus Safety database

2 years of experience in Drug Safety/Pharmacovigilance

SAE case processing along with narrative writing (both clinical trials and post marketed) and experience in providing medical Information to healthcare professionals and consumers.

Thorough understanding of ICH, GCP guidelines, and quality experience in individual case processing with reputed pharmaceutical giants.

Involvement in various project related training to fellow colleagues. Also responsible for peer QC of cases.

Pharmacovigilance lead for multiple clinical trial studies belonging to different therapeutic areas like neuromuscular, Immunology, infectious diseases, etc. for various clients.

An energetic, self-motivated team player with hands on experience in case processing, narrative writing and call handling for medical information queries.

Trained on ArisG, Argus and Clintrial database.

Statistical Data analysis using SAS, Stata, SPSS, Epi Info

EDUCATION

University of Nebraska Medical Center Expected (Jul, 2012)

M.P.H Epidemiology,

Graduate Assistant

MET Institute of Pharmacy June, 2008

Bachelors of Pharmacy

EXPERIENCE

I3 Drugsafety Nov 2009-Aug 2010

Pharmacovigilance Co-ordinator

• Analyzed safety data for signal detection.

• Process (performed Medical coding, writing individual case narratives) adverse events for clinical trials, adverse events described in literature (research papers and peer reviewed articles) and spontaneous cases (individual case safety report).

• Report adverse events to federal agencies like FDA, EMEA (Submissions).

• Enter safety information into the safety database and develop a medically precise and succinct narrative.

• Participate as a team member in the process of developing and reviewing standard operating procedures (SOP)

• Participate as team member to write Clinical Trial Protocols and Safety Monitoring plans

• Write aggregate reports including PSUR’s and PADERS’s for regulatory submissions to FDA and EMEA.

• Write Clinical Study Reports for a molecule under clinical trial phase II and III. (individual responsibility)

• Write reports after analyzing the safety and efficacy for the product for regulatory submissions.

• Worked on following projects in regards to responsibilities mentioned above

• (for submission for European Medicines Agency):

H1N1 vaccine

Study lead for Phase II clinical trials for a product for Duchenne muscular dystrophy (DMD)

Clinical trials which involved effect of monoclonal antibody (Ipilimumab) for melanoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hormone-refractory prostate cancer

Cognizant Technology Solutions: Sept 2008 - Nov 2009

Junior Data Analyst

• Reviewed and assessed all source documents, and compile data in Argus safety database

• Performed triage for incoming initial and follow-up reports

• Coded events using MedDRA dictionary

• Coded products using the WHO drug dictionary

• Performed labeling assessment of adverse event, comparing adverse event to adverse events previously reported in the labeling documents such as CORE, IB, SPC and USPI

• Generated Follow-up letters to be sent to consumers, physicians and other manufacturers

• Ensured that reports are generated and are fit for submission to regulatory authorities

• Processed Spontaneous cases, Solicited cases, Clinical trial cases, Licensed party product cases and Literature cases

• Identified and documented adverse events per the information provided by caller (Consumer or health care Professional)

• Performed Book-in, duplicate search, and Data entry activities whenever required.

• Performed electronic unblinding of cases for various studies.

• Provided medical information over telephone, e-mails, facsimile to health care providers and consumers

• Processed product quality complaints.

AREAS OF INTEREST:

• Risk management, Pharmacovigilance planning

• Design and conduct epidemiological studies

PRESENTATIONS:

• Undergraduate seminars:

New Drug Delivery System- Microsponge (a sustained drug delivery system)

Nicotine Replacement Therapy

• During Employment

• These are the guidelines to be followed in various phases of Clinical Trials.

i. ICH E 2 A

Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

ii. E2B Date elements for Transmission of Individual case Safety reports

iii. ICH E 2 C

Clinical Safety Data Management:

Periodic Safety Update Reports for Marketed Drugs

iv. ICH E2E: Pharmacovigilance Planning (PvP)

v. Volume 9A (guidelines for European Union)

vi. Clinical Trials Overview

COMPUTER SKILLS:

• MS Office (Excel, PowerPoint, Word, Accsess)

• SPSS 18, SAS 9.2, Stata, Epi Info

• Safety Databases ( Argus, ARISg,)

REFERENCES

1) Mr. Jayawant Fuke

Medical Director – i3 Drugsafety

Email address: ********.****@************.***

Tel no: 91-981*******

2) Dr. Shinobu Watanabe-Galloway

Associate Professor-Epidemiology

University of Nebraska Medical Center

College of Public Health

Phone: 402-***-****

Fax: 402-***-****

Email: *********@****.***

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