Medical Safety

AMIT SHAH, MD **** Merrywood Drive . Edison, NJ **817

***********@*****.*** . m:732-***-**** .

h:732-***-****

Pharmacovigilance Physician

* + years of success driving research, development, and execution of

pharmacovigilance

Physician and team leader noted for concrete experience in

Pharmacovigilance and clinical practice with strong emphasis on accurate

analysis, evaluation and interpretation of single case and aggregate

adverse event data. Proficient in reviewing and analyzing aggregate safety

reports. Acknowledged for hands-on competence in developing Risk

Management Plans for high-profile drugs.

Highlights of Expertise

Pharmacovigilance US/EU/AP/LA Regulations & ICH Communication with

Risk Management Plan (RMP) Guidelines Global Health

Medical Writing & Reviewing Authorities

RiskMAPs Preparation Literature Review Internal

Safety Signal Detection & Aggregate Reporting Medicine/Cardiology/

Evaluation Oncology/Pulmonology/

Nephrology/Neurology/

Critical Care Knowledge

Career Summary

Ikaria Inc., Hampton, NJ

PHARMACOVIGILANCE Physician (September 2012 to September 2013)

. Supported the Director with development and maintenance of RMPs and

riskMAPs for marketed products and drugs in clinical trials

. Detected and evaluated safety signals based on ICSRs, cumulative

data assessment, and by using other signal detection methods

including PRR. Provided data-driven decisions and communicated

these findings proactively and effectively to the clinical team

. Contributed to the identification and determination of Events of

Interest

. Actively participated and developed presentations for the Safety

Management Team (SMT) and Post-Marketing Safety Surveillance Team

(PMSST)

. Responded to ad hoc queries from Global Regulatory Health

Authorities (FDA, EMEA, MHRA)

. Co-authored and reviewed aggregate reports including DSURs, PSURs,

PADERs, PBRERs, and other ad-hoc safety reports

. Collaborated in the development of study protocols, package

inserts, IBs, ICFs, and CCDS

. Actively participated in health authority or ISO audits

. Performed literature reviews of drugs in development and marketed

products

. Completed medical review of SAEs & non-serious AEs related to drug

and/or device for clinical trials in phases I to III and

spontaneous post-marketing reports, including input for medical

coding of events according to standard MedDRA terminology and

review of seriousness, expectedness/listedness and causality of

each reported event

. Developed SUSAR narratives, performed risk assessment, initiated

the unblinding process (as appropriate), and made the report

available for distribution

. Prepared and submitted expedited reports to regulatory authorities

and partner companies including IND, NDA, and MDR reports and

authored Investigator Letters

. Reviewed queries drafted by PV staff and provided additional

queries for pertinent information regarding ICSR

. Performed QC of ICSRs for accuracy and completeness

. Worked with the clinical team regarding various safety matters

including training sites in adequate reporting of drug and device

SAEs & non-serious AEs and answering site queries

. Developed, maintained and optimized SOPs, work instructions,

policies, procedures and standards for safety surveillance, signal

assessment and management, and risk management

. Delivered expertise and leadership for medical safety-related

training activities in departmental and company-wide programs,

including continuing education and professional development for the

PV staff

. Interacted on a regular basis with CRO, data management, and

healthcare professionals to resolve safety related issues

. Trained and mentored new PV staff with the use of ARGUS

U.S. Pharma Lab, North Brunswick, NJ

Drug Safety Associate / Medical Reviewer (February 2010 to May 2012)

. Conducted medical review of individual case safety reports (ICSR)

for AEs and SAEs, including MedDRA coding, internal causality

assessments, expectedness/listedness, and determined regulatory

reportability of clinical trial cases and spontaneous post-

marketing cases

. Performed literature reviews for investigational new drugs and post-

marketing products

. Independently evaluated case source, adverse event, and patient

information to determine report status (initial vs. follow-up) by

executing data queries within the safety database

. Triaged cases by reporting criteria, expedited reporting vs.

periodic reporting, based on an understanding of "seriousness" and

"expectedness" criteria and in the case of clinical studies, on

"causality" assessment and "listedness"

. Entered safety data into ARGUS with the ability to interpret the

received report sufficiently to complete all necessary fields

. Accurately entered data from source documents/medical reports and

proofread for completeness, accuracy, and consistency of

information

. Drafted individual case summary reports and wrote concise specific

narratives as per company/product conventions

. Utilized coding software to assign MedDRA codes to clinical events

and WHODrug codes to medications

. Identified data requiring further follow-up and drafted queries

. Assisted in submission of expedited reports to regulatory agencies

and partner companies including 15-day Alert Reports, 7/15-day IND

reports, and NDA reports.

UMDNJ, Newark, NJ

Clinical research associate (September 2009 to January 2010)

. Monitored, evaluated, and completed follow-up of relevant medical

data and adverse events for participants in clinical trial

. Coordinated and completed all phases of clinical trial with in-

depth knowledge of SOPs and FDA GCP-ICH guidelines

. Prepared comprehensive, concise, and accurate narratives describing

the adverse event reported in source documents

. Strong focus on adherence to study protocol for treatment and

detailed logging of all medical and diagnostic data to ensure

quality research.

Additional Experience

Medical Student/Intern (July 2008 to August 2009) - Richmond University

Medical Center, Staten Island, NY

Medical Student/Intern (July 2007 to June 2008) - Jackson Park Hospital,

Chicago, IL

Clinical Research Scientist (June 2002 to May 2005) - Colgate-Palmolive,

Piscataway, NJ

Biochemistry Intern (June 2001 to August 2001) - Bristol-Myers Squibb,

New Brunswick, NJ

1 Education & Certifications

Doctor of Medicine (MD), North Brunswick, NJ (2009)

Ross University - School of Medicine

Bachelor of Science (BS) - Biochemistry, Economics Minor (2002)

Rutgers University, New Brunswick, New Jersey

Technical Proficiencies

. Tools: MS Project, MS Office Suite 2010 (Access, Excel, Outlook,

PowerPoint, Word)

. Drug Safety Database: ARGUS, ARISg, MedDRA, WHODrug

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