Manager Safety
Resume:
Shardul Sohani
** * ******, *** *** San Mateo, CA, 94402
Phone: 804-***-****; *******.******@*****.***
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-***-****; *******.******@*****.***
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-***-****; *******.******@*****.***
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-***-****; *******.******@*****.***
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: ********.****@************.***
Tel no: 91-981*******, +91-954*******
Gaurav Mehta
Associate Manager- Synowledge
Phone: +91-888*******
Email- ******.*****@**********.***
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: *******.****@****.***
Shardul Sohani Phone: 804-***-****; *******.******@*****.***
Shardul Sohani Phone: 804-***-****; *******.******@*****.***
Contact this candidate