Safety Medical

HIGHLIGHTS OF QUALIFICATIONS

Thorough clinical and technical expertise in oncology, immunology, nephrology, biologics, monoclonal antibodies, immunosuppressant drugs and anti-cancer therapies

In-depth understanding of FDA, EMA, GCP, GVP and ICH guidelines gained through more than 5 years pharmacovigilance and clinical research experience in North America

Technical knowledge and expertise in post-marketing drug safety surveillance

Strong command over Drug Development Process (phase I – IV) achieved by Masters’ study in Clinical Epidemiology and extensive clinical research experience

Operational knowledge of safety data analysis and aggregate reports preparation demonstrated by analyzing epidemiological data in Rheumatology and authoring DSMB and Quarterly Safety reports

Well experienced in database management (clinical and safety databases)

Self-starter, focused achiever and detail-oriented, proven by successfully completing Master’s thesis during graduate study at University of Western Ontario

Excellent time-management skills demonstrated by meeting deadlines for regulatory submissions and completing pharmacovigilance projects at Axiom Real-Time Metrics

Strong leadership skills demonstrated by supervising clinical coding team (MedDRA and WHODrug) at Axiom Real-Time Metrics

Strong critical thinking and analytical skills proven by experience examining safety data from literature and observational studies

Excellent communication skills demonstrated at various national and international conferences through scientific presentations

CAREER OVERVIEW

Pharmacovigilance Specialist April 2015 - Present

Axiom Real-Time Metrics, Toronto, Canada

Manage and lead PV projects through team training, collaboration, regular meetings and tasks supervision

Lead the ELAD (Extracorporeal Liver Assist Device - Liver Dialysis Machine) study and assist the other oncology and immunology studies for pharmacovigilance activities

Process global cases, generate case relevant queries, follow-up on queries, perform quality review, and reconcile safety information for drugs and device SAEs

Review and interpret the safety information for clinical significance; comprehensively assess SAEs and SUSARs for seriousness, causality and expectedness and discuss with medical monitors

Communicate with health care professionals, study sponsors and regulatory authorities for adverse drug reaction investigations and safety inquiries

Author precise case narratives by extracting relevant clinical information from CRFs and source documents

Prepare ICSRs and other safety reports for global regulatory reporting including FDA, Health Canada and EMA

Author Safety Management Plans for various drug, biologic and device clinical trials in oncology, hematology, hepatology and immunology disease areas

Provide review and suggest necessary updates for the safety section of study protocols and study reports

Analyze adverse event data and author DSMB reports for oncology and hepatology clinical trials; prepare clinical trial line listings for DSUR and IND reports

Search and review medical and scientific literature from epidemiological and clinical trial reports to identify new safety information for device clinical trials

Train and supervise MedDRA/WHODRUG coding team; write coding conventions documents for various clinical trials; discuss coding with clients and get coding approval

Facilitate internal and external client meetings for safety cases, regulatory and aggregate reports discussion; review meeting agenda and meeting minutes

Manage and maintain good customer relationships both internally with Axiom affiliates and externally with key customers

Generate, review and update departmental SOPs and IWIs related to drug safety and medical information

Work in alliance with Axiom’s internal departments such as data management, clinical operation, project management and quality assurance

Clinical Research Fellow 2013-2015

University of Western Ontario, London, ON

Conducted systematic review of literature (Medline, EMBASE) for biologics use in autoimmune diseases; consulted with academic experts on medical matters related to biologics safety

Completed meta-analysis on the effect of methotrexate on cardiovascular events, and all-cause mortality in patients with autoimmune disease

Report link: http://ir.lib.uwo.ca/cgi/viewcontent.cgi?article=4242&context=etd)

Analysed data from epidemiological studies and prepared tabulated and graphical reports with appropriate biostatistical methods for observational studies data

Research Associate 2011-2013

Dr. William G. Bensen Medicine Professional Corporation, Hamilton, Canada

Extracted relevant data on demographic, clinical and laboratory variables from patient charts and EMR of rheumatoid and psoriatic arthritis patients

Analyzed clinical database using appropriate statistical methods and compared the effectiveness, safety and drug survival rate of etanercept, infliximab, adalimumab and glimumab

Authored study reports using tabulated and graphical charts and discussed results with various stake holders

Actively participated in scientific sessions by presenting posters in the American College of Rheumatology and Canadian Rheumatology annual meetings

Medical Associate, Clinical Operations (part-time) 2011-2013 Biopharma Services Inc., Toronto, Canada

Monitored study subjects for medical conditions and adverse events in various bioequivalence studies

Drug Safety Physician 2008-2011

Claris Lifesciences Limited, Ahmedabad, India

Conducted analysis of adverse event and other safety data, identified and investigated safety issues of the products

Ensured accuracy, timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities

Discussed and presented safety profile of products at internal and external meetings

EDUCATION

Master of Science (MSc) 2013-2015

University of Western Ontario, Canada

Epidemiology and Biostatistics

Doctor of Medicine (MD) 2002-2005

Medical College Baroda, India

Bachelor of Medicine and Bachelor of Surgery (MBBS) 2002

Medical College Baroda, India

PUBLICATIONS AND CONFERENCE PRESENTATIONS

Shah AR, Barra LJ, Hackam DG. Methotrexate and cardiovascular events: systematic review and meta-analysis. Circulation. Under review 2017. http://ir.lib.uwo.ca/cgi/viewcontent.cgi?article=4242&context=etd

Hanna BD, Shah AR. Drug survival and long-term dose comparison of etanercept and infliximab in rheumatoid arthritis patients [abstract]. Arthritis Rheu. 2011; 63(Suppl.10):477

Chow A, Soucy E, Shah A, Got M. Comparison of drug survival, safety and doses of etanercept, infliximab and adalimumab in rheumatoid arthritis patients: thirteen years Canadian clinical practice experience [abstract]. Ann Rheum Dis. 2013;72(Suppl. 3):867

Lau AN, Shah A, Deamude M, Mech C, Bensen R, Bensen WG. Effectiveness of etanercept in elderly patients with rheumatoid arthritis: A single center retrospective study [abstract]. Arthritis Rheum. 2013;65(Suppl. 10):627

Saldanha M, Brown K, Heap D, Mech C, Deamude M, Kislinsky K, Mc-Clory D, Shah A, Bensen WG. A study to determine patient satisfaction with a nurse-led injection clinic in rheumatology [abstract]. Arthritis Rheum. 2013;65(Suppl. 10):819

Bensen WG, Bensen W, Deamude M, Mech C, Bensen R, Lau AN, Shah A. Validation of Snapshot, a rheumatoid arthritis assessment tool, against CDAI, DAS28 (ESR), and DAS28 (CRP) in Canadian patients with rheumatoid arthritis [abstract]. Arthritis Rheum. 2014;66(Suppl. 11):156

Sekhon S, Rai R, McClory D, Whiskin C, Deamude M, Mech C, Vanstone L, Shah A, Lau AN, Bensen W. Patient perspectives on the introduction of subsequent entry biologics in Canada [abstract]. Arthritis Rheum. 2014;66(Suppl. 11):663

Lau A, Shah A, Kanellos M, Heap D, Whiskin C, Bensen R, Bensen W. A retrospective study to evaluate the effectiveness, drug survival and safety of golimumab in rheumatoid arthritis patients in Canadian rheumatology practice. 2013 CRA Annual Scientific Meeting and AHPA Annual Meeting, February 2013. http://rheum.ca/images/documents/2013_Abstracts_Selected_for_Poster_Presentation_rev_for_JRheum.pdf

Lau A, Shah A, Kanellos M, Heap D, Whiskin C, Bensen R, Bensen W. Golimumab start-stop: drug discontinuation due to financial constraints; experience from a single Hamilton center. 2013 CRA Annual Scientific Meeting and AHPA Annual Meeting, February 2013. Available from: http://rheum.ca/images/documents/2013_Abstracts_Selected_for_Poster_Presentation_rev_for_JRheum.pdf

Got M, Shah A, Lau A, Mech C, Deamude M, Bensen R, Bensen W. A retrospective study to evaluate the safety, efficacy, and drug survival of Rituximab in rheumatoid arthritis patients in a single Canadian practice. 2013 CRA Annual Scientific Meeting and AHPA Annual Meeting, February 2013. Available from: http://rheum.ca/images/documents/2013_Abstracts_Selected_for_Poster_Presentation_rev_for_JRheum.pdf

Shah A, Got M, Lau A, Mech C, Deamude M, Bensen R, Bensen W. A retrospective study to evaluate the effectiveness, safety and drug survival of Tocilizumab in rheumatoid arthritis patients in a single Hamilton practice.

2013 CRA Annual Scientific Meeting and AHPA Annual Meeting, February 2013. Available from: http://rheum.ca/images/documents/2013_Abstracts_Selected_for_Poster_Presentation_rev_for_JRheum.pdf

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