Shardul Sohani

** * ******, *** *** San Mateo, CA, 94402

Phone: 804-***-****; acfmtm@r.postjobfree.com

OBJECTIVE

To be associated with a progressive organization that gives me the scope to apply my

knowledge and skills for mutual growth.

EDUCATION

University of Nebraska Medical Center (College of Public Health) summer, 2013

M.P.H,Epidemiology

Mumbai University (MET Institute of Pharmacy) June, 2008

Bachelors of Pharmacy

EXPERIENCE

Clinical Safety Associate

Genentech, June 2013- Till date

• Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety

reporting requirements.

• Performed a review of ancillary documentation accompanying ICSR reports and identified

pertinent clinical information for incorporation into the case narrative.

• Performed Data Capture and Quality Review for all molecules and served as a backup for

additional projects.

• Identified and initiated requests for case follow up for clinical trials and post marketing

adverse events.

• Worked with Submissions team responsible to properly identify US regulatory reporting

requirements.

• Demonstrated a general understanding of appropriate labeling documents for assigned

project(s).

• Demonstrated knowledge and understanding of safety exchange agreements.

• Participated on Study Management Teams

• Assisted in the development of drug safety presentation for investigator meeting

presentations.

• Assisted in clinical trial reconciliation process.

• Organized work load to ensure compliance with regulatory timelines for ICSR reporting.

• Ensured departmental workflow processes and timelines are followed.

Shardul Sohani Phone: 804-***-****; acfmtm@r.postjobfree.com

Research Assistant

University of Nebraska Medical Center, Jan 11- April 13

• Part of an Indo-US NIH-funded clinical research team

• Studied development of gastro intestinal flora in low birth weight infants, in developed and

developing countries.

• Use of pro-biotic (Lactobacillus plantarum) to curb the colonization of gram negative

bacteria in infants.

• Impact of Receipt of Antiretroviral Therapy (ART) For More Than 2 Years in Relation to

Non Infections Co-morbidities (NICMs)

• Experimental study evaluate computer-enabled intervention to prevent and manage

metabolic syndrome

• Part of a R21 HS21321-01A1, Feasibility of a touch screen computer based breast-feeding

educational support programresearch team that examines feasibility of a touch screen

computer based breastfeeding educational support program

• Factors affecting wound healing

• Medical Coding

• Statistical analysis using SPSS and SAS 9.2

Responsibilities

o DNA extraction

o Polymerase chain reaction (PCR) Real-time PCR

o Denaturing Gradient Gel Electrophoresis (DGGE)

o Interpretation of the gels and translating them into quantitative data

o Safety plan for known adverse events

o Statistical analysis using SAS 9.2

o Statistical analysis using SPSS and SAS 9.2

o Data Coding

o Critical analysis of scientific literature

Pharmacovigilance Co-ordinator

inVentiv Health Clinical, Nov 09 –Aug 10

Projects:

• 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

Responsibilities:

o Analyzed safety data for signal detection.

o Processed adverse events for clinical trials, adverse events described in scientific

literature and spontaneous cases.

Shardul Sohani Phone: 804-***-****; acfmtm@r.postjobfree.com

o Reported adverse events to federal agencies like FDA, EMEA.

o Entered safety information into the safety database and develop a medically

precise and succinct narrative.

o Participated as a team member in the process of developing and reviewing

standard operating procedures (SOP)

o Participated as team member to write Clinical Trial Protocols and Safety Monitoring

plans

o Wrote aggregate reports for regulatory submissions to FDA and EMEA.

o Wrote Clinical Study Reports for a molecule under clinical trial phase II and III.

(individual responsibility)

o Wrote reports after analyzing the safety and efficacy for the product for regulatory

submissions.

o Participated in the recruitment process under the guidance of the Manager.

Junior Data Analyst

Cognizant Technology Solutions: Sept 08 - Nov 09

Responsibilities:

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

database

o Performed triage for incoming initial and follow-up reports

o Coded events using MedDRA dictionary

o Coded products using the WHO drug dictionary

o Performed labeling assessment of adverse events.

o Generated follow-up letters to be sent to consumers, physicians and other

manufacturers

o Ensured that reports are generated and are fit for submission to regulatory

authorities

o Processed Spontaneous cases, Solicited cases, Clinical trial cases, Licensed party

product cases and Literature cases

o Identified and documented adverse events per the information provided by caller

(Consumer or health care Professional)

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

o Performed electronic un-blinding of cases for various studies.

o Provided medical information over telephone, e-mails, facsimile to health care

providers and consumers

o Processed product quality complaints.

o Worked as smoking cessation counselor.

Trainings Conducted

ICH E 2 AClinical Safety Data Management: Definitions and Standards for

•

Expedited Reporting

E2B Date elements for Transmission of Individual case Safety reports

•

ICH E 2 C Clinical Safety Data Management

•

ICH E2E: Pharmacovigilance Planning (PvP)

•

Volume 9A (guidelines for European Union)

•

Shardul Sohani Phone: 804-***-****; acfmtm@r.postjobfree.com

Clinical Trials Overview

•

Writing Periodic Safety Update Reports for Marketed Drugs

•

Presentations and Publications:

•

Evaluation of sexually transmitted infection related health information on

•

internet(Ashish Joshi, MD, PhD, MPH, ShardulSohani, MPH, ShireenRajaram,

PhD, Ashoo Grover) Presented at 141st APHA Annual Meeting and

Exposition.November 6, 2013

Impact of Receipt of Antiretroviral Therapy (ART) For More Than 2 Years in

•

Relation to Non Infections Co-morbidities (NICMs) (Cardiovascular Disease,

Diabetes, Hypertension, Liver Disease, and Kidney Disease) in Older HIV-

Infected Patients. (Sohani, Shardul, B.Pharm; Swindells, Susan, MBBS;

Baojiang Chen, Phd; Islam, Monirul, MD Phd)

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

•

(Nov 2006)

Role of music in the management of chronic obstructive pulmonary disease

•

(COPD): A literature review. (Atman Panigrahi, ShardulSohani, ChiomaAmadi,

Ashish Joshi, Technology and health care: official journal of the European

Society for Engineering and Medicine)

Skills:

SAS 9.2, SPSS 18, Stata, Epi Info

•

Safety Databases ( Argus, ARISg)

•

MS Office

•

REFERENCES

Dr. Jayawant Fuke, MD

Medical Director and PV Director, India – i3 Drugsafety

Email address: acfmtm@r.postjobfree.com

Tel no: 91-981*******, +91-954*******

Gaurav Mehta

Associate Manager- Synowledge

Phone: +91-888*******

Email- acfmtm@r.postjobfree.com

Tara Johnson RN, BSN

US Drug Safety Operations Manager

Genentech, a Member of the Roche Group

1 DNA Way

South San Francisco, CA. 94080

Office: 650-***-****

Email: acfmtm@r.postjobfree.com

Shardul Sohani Phone: 804-***-****; acfmtm@r.postjobfree.com

Shardul Sohani Phone: 804-***-****; acfmtm@r.postjobfree.com

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