Safety Medical
Resume:
Minal Dhebaria, PharmD, RPh
* ******** **** **** *** # 518
Philadelphia, PA 19103
********@*****.***
EDUCATION AND CERTIFICATIONS
Rutgers University Pharmaceutical Industry Fellowship Program, April 2011
New Jersey Board Certified Licensed Pharmacist, August 2009
Ernest Mario School of Pharmacy Graduate, May 2009
SKILLS
MedDRA, ARGUS, ADVENT, ORACLE, PubMed, Micromedex, Microsoft Office, Microsoft Excel, Microsoft
PowerPoint, Adobe Photoshop, Windows XP/2000
PROFESSIONAL EXPERIENCE
Bayer HealthCare Pharmaceuticals, Wayne, NJ
Senior Medical Record Extractor/Pharmacovigilance Case Associate- Global Pharmacovigilance April 2011 -
Present
• Perform case processing by promptly and accurately interpreting and entering serious and non-serious initial
and follow-up adverse events case reports into the local and global ARGUS safety database for distribution in
accordance with global safety regulations and SOPs (Standard Operating Procedures)
• Accurately code adverse events (using MedDRA [Medical Dictionary for Regulatory Activities]), event
outcomes, suspect products and treatments (using Who-Drug Dictionary), medical history, laboratory
parameters, reporter information, and etc.
• Assess reporter and company causality and seriousness accordingly
• Utilize current CCDS (Company Core Data Sheet) to assess global listedness
• Request all pertinent follow up information for the completion of case reports for adverse events within
specific timelines as prescribed by global regulations and SOPs
• Verify, as prescribed by regulatory guidelines, that trade names are translated into the correct INN
(International Non-proprietary Name)
• Generate comprehensive case narratives
• Process Product Technical Complaints associated with or without adverse events
• Perform duplicate checks in safety database for each case report received to ensure duplicate cases are not
created and reported to the regulatory authorities
• Assess lock, distribute, and archive of case reports according to global regulations and SOPs
• Serve as a mentor and train new hires in case processing for various therapeutic areas including Oncology,
Women’s Health, Primary Care, and Consumer Care products
• Perform QC (Quality Check) of case reports entered into the local and global ARGUS safety database by other
case processors
• Review case reports by verifying receipt dates, initials, date of birth, adverse events, suspect products, and
treatments
• Perform case corrections for case reports as needed and document in company database accordingly
• Provide constructive feedback to individuals regarding any case corrections
• Medically review, evaluate, and extract pertinent information (such as adverse events of special interest,
suspect products, event outcomes, medical and drug history, laboratory parameters, reporter information, and
etc.) received from legal, medical, and pharmacy records for spontaneous initial and follow up reports in
accordance with legal and US FDA (Food and Drug Administration) safety regulations
• Create comprehensive patient narratives of such case reports as determined by regulatory and SOPs
• Utilize local and global ARGUS safety database and MedWatch 3500A Drug and CIOMs I forms to
review safety information for such cases
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• Served as the Team Lead for a CAPA (Corrective and Preventive Actions) project implemented secondary to
an inspection finding
• Reviewed MedWatch 3500A Drug forms, CIOMS I forms, and excel output of potentially late serious
spontaneous and clinical trial cases from the global safety ARGUS database to identify any cases that are
considered non-late under given FDA waiver deadlines
• Distributed such cases on a daily basis to the team members
• Collated cases identified as non-late by the team members and sent them accordingly to compliance
department
• Assisted team members with any questions and provided additional review of cases if needed
• Communicated questions and any issues regarding cases to compliance department
Hoffmann-La Roche, Inc., Nutley, NJ
Post-Doctoral Fellow, Clinical Science-Inflammation July 2010- April 2011
• Actively participated in multiple study conduct activities for two global Phase III studies
• Assisted the Clinical Specialist with protocol amendments
• Reviewed protocols, protocol synopses, study-related documents, flow charts for Interactive Voice
Response System (IVRS) applications, and patient educational materials
• Conducted patient data review in the Clinical Safety database and sending queries to sites as to resolve
discrepancies
• Served as lead in charge of the creation and maintenance of Informed Consent Forms (ICFs) for two global
Phase III studies
• Ensured consistency between the protocol and ICFs during protocol amendments
• Reviewed, analyzed, and summarized safety data from clinical trials, post-marketing surveillance studies,
and compassionate use programs for incorporation into ICFs
• Reviewed and amended the ICFs for re-submission to local institutional review board (IRBs)
• Performed analysis of safety data on specific adverse events of special interest
• Generated responses for Rapporteur questions received from the European Medicines Agency (EMA)
secondary to a filing
• Contributed to preparing filing documents for the FDA and EMA
• Assisted the Clinical Specialist with the creation of a safety document on an adverse event of special
interest
• Stratified and summarized relevant data from clinical trials and post-marketing surveillance studies
• Calculated incidence rates from clinical trials and post-marketing surveillance studies for comparison
to background incidence rates
• Coordinated the review and finalization of the safety document
• Conducted literature searches and provided an epidemiologic summary of selected diseases
• Participated in preparations for a FDA Advisory Committee
• Significantly contributed to the creation of safety and efficacy slides
• Served as the contact for assimilating issue profiles from all functions and contacting Key Opinion Leaders
(KOLs)
Hoffmann-La Roche, Inc., Nutley, NJ
Post-Doctoral Fellow, Drug Safety-Inflammation July 2009- July 2010
• Significantly contributed to the Periodic Safety Update Reports (PSURs) and co-authored few Drug Safety
Reports (DSRs)
• Reviewed, evaluated, and assessed cases of adverse events from the safety database
• Organized cases of adverse events into tables capturing key parameters for aggregate review
• Performed searches and summaries of epidemiologic data on certain disease states
• Provided comprehensive and accurate clinical narratives of cases of adverse events
• Assisted in the update of MedDRA baskets for specific adverse events of special interest to ensure consistency
in reporting events to health authorities
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• Served as the Drug Safety lead for submission of a supplemental Biologic License Application (sBLA) to the
FDA
• Coordinated the safety database cut by sending queries for validated data
• Reviewed, evaluated, and assessed cases of adverse events from the safety database
• Organized cases of adverse events into tables capturing key parameters for aggregate review
• Prepared responses for multiple queries received from affiliates
• Performed literature searches and utilized internal safety reference documents to respond to various
medical questions received from sites and investigators
• Sent queries requesting validated data from the safety database
• Utilized a signal detection tool to create a monthly report summarizing potential safety signals
• Served as the lead for a cross functional work-stream implemented secondary to a EMA safety inspection
• Created a guidance document and memos for monitors and investigators which provided details
surrounding reporting requirements, documentation, and medical review for the adverse events of special
interest for a product
• Produced draft electronic forms for the clinical database to capture specific elements on adverse events of
special interest
• Assisted the Drug Safety Associate Director in the creation of training slides for incorporation into the
company training database and in the organization of several live global trainings presented to clinical trial
monitors and investigators
• Contributed to generating responses secondary to requests received from a EMA safety inspection
• Maintained and updated specific pregnancy data for a product on a monthly basis
• Finalized the search strategy for identifying pregnancy cases within the safety database and captured key
elements from reported pregnancy cases into a master file for the team
Rutgers University Pharmaceutical Industry Fellowship Program
Post-Doctoral Fellow/Adjunct Faculty July 2009-Present
• Chaired the Lead Contact Committee for the Hoffmann-La Roche Fellowship Program
• Interviewed potential candidates for the Fellowship program and organized the Hoffmann-La Roche
Fellowship Orientation for incoming fellows
• Lectured laboratory sessions for Pharm.D students on blood pressure monitoring
Novartis Pharmaceuticals Corporation, East Hanover, NJ
Safety Intern, Drug Safety and Epidemiology June 2007-August 2007
• Received and documented adverse events received from the call center in to the safety database
• Assisted the Safety Scientist in the evaluation and assessment of cases of adverse events for potential safety
signals
INDUSTRIAL CLERKSHIP
Ortho McNeil Pharmaceuticals, Raritan, NJ
Pharmacy Graduate Student, Drug Information November 2008-December 2008
• Updated consumer and physician reference letters on adverse events by performing and summarizing
clinical literature searches
RELEVANT CLINICAL CLERKSHIPS
• Critical Care at Robert Wood Johnson University Hospital: Preceptor - Frank Hughes, Pharm.D
• Infectious Disease at St. Michael’s Medical Center: Preceptor - Humberto Jimenez, Pharm.D
WORK HISTORY
Walgreen’s Pharmacy, Colonia, NJ
Pharmacy Technician/Graduate Intern September 2002- July 2009
• Assisted the pharmacist in filling and compounding prescriptions, including controlled substances
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• Received and entered prescriptions, patient history, and insurance information into the computer system
and counseled patients accordingly
PROFESSIONAL AFFILIATIONS
• DIA (Drug Information Association): 2009 to Present
• APhA (American Pharmacists Association): 2006 to Present
• ASHP (The American Society of Health-System Pharmacists): 2006 to Present
• Rho Chi Honor Society: 2006 to Present
PRESENTATIONS
• Presented on “Why Biologics? Incentives, Mergers, and Promising Therapies” to Rutgers Fellowship
Fellows and Preceptors, 2009
• Presented on “Drug Safety” to potential Rutgers Pharmaceutical Industry Fellowship Program candidates,
2009
• Presented on “Post-Marketing Adverse Event Reporting for Over-The-Counter Products” to Rutgers
Fellowship Fellows and Preceptors, 2011
PROFESSIONAL TRAININGS
• Using Safety Risk Management Programs to Enhance the Safety of Medicines 2009
• Risk Evaluation and Mitigation Strategy (REMS) Training 2010
• DIA: FDA Discusses Signaling Using Data Mining Results 2010
REFERENCES
Available upon request
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