Medical Safety
Resume:
Deepa S. Patel
***.*****.*@*****.***
Professional Profile
• Over 5 years of concrete experience in Drug Safety / Pharmacovigilance.
• Analyze, evaluate and interpret single case and aggregate adverse event data.
• Proficient in viewing and analyzing aggregate safety reports (SUSAR, PSURs, PADERs, EU
CTD Annual Safety Reports, and Semi-Annual line-listings of Suspected Unexpected Serious
Adverse Reactions) for submission to world-wide Regulatory Agencies
• Hands-on competence in developing Risk Management Plans for high-profile drugs
• Extensive experience responding to Ad Hoc queries from Global Regulatory Health Authorities
(FDA, EMEA, MHRA)
• Experience in preparation and drafting of ad-hoc and aggregate regulatory reports (NDA) and
labeling support documents
• Safety physician with in depth knowledge of International Drug Safety reporting
regulations and guidelines.
• Oversee the work of the CRO’s in order to ensure compliance with national and international
regulations and requirements.
• Therapeutic area Oncology, Neuroscience, Cardiovascular, Infectious disease, Respiratory,
and OTC products.
• Familiar with ARGUS database, MedDRA. And WHODRL
Core Competencies: Subject Matter Expert (SME) in Pharmacovigilance and Epidemiology
(Aggregate Safety Reports and Medical Review), Signal Detection, Medical Writing
(Regulatory), Regulatory compliance, Clinical Research, Formation of Human Ethical
Committee in accordance with ICH-GCP guidelines, Cardiology and Critical Care Practice.
Drug Safety: Triaging, case processing, MedDRA coding, WHO drug coding, medical
evaluation and narrative writing, familiarity in working on different therapeutic areas
Databases: Knowledge and proficiency with drug safety Argus database applications,
Medical skills: Medicine, Epidemiology, Biostatistics.
Reaserch: Immunological response on Hepatitis C virus.
G-protein-coupled receptor domain overexpression in Halobacterium salinarum:
Long-range transmembrane interactions in heptahelical membrane proteins
In Pharmacovigilance: Experienced in ICSR review, Literature review, ARGUS database,
MedDRA coding, SUSAR/PSUR/PADER Medical review, Signal detection, working with
global PV teams, managing PV teams.
In Medical Monitoring: Experienced in Protocol development and Review, protocol query
resolution, Recruitment of study subjects, SAE/AE resolution, Oncology clinical trial
management, Patient profile review in database.
Specialties: Triaging and Medical review of ICSR, Literature review, Medical monitoring,
PSUR/PADER Medical review, ARGUS, MedDRA coding review, SAE management, Oncology
clinical trials, Signal detection, Endpoint medical review, Medical Review for Patient Profile,
Good Clinical Practice.
Education:
MD – Medical University of Lublin in Poland (Poland, Chicago)
Bachelors in Biology – East Carolina University
Experience:
Genzyme Ridgefield, NJ
Drug Safety Physician Jan-2012 to Current
Job Purpose
Responsible for carrying out pharmacovigilance activities on a product or group of products,
including single case processing, aggregate reporting, signal detection and evaluation of PV
database. Contribute to the benefit risk evaluation and to safety risk management. Support the
on-going safety needs of both clinical development and post marketed products. These
responsibilities included but not are limited to:
• Perform single case medical assessment, including the determination of seriousness,
expectedness/listedness/labeledness, and causality of adverse events in compliance with current
regulations, internal and external guidance documents, Standard Operating Procedures, Safety
Job Aids, the ARGUS User Reference Guide and case processing/coding conventions.
• Perform final medical review and assess causality of all serious adverse experiences from
Phase I-IV clinical trials and adverse events from post-marketing spontaneous reports and other
sources (U.S. and foreign).
• Maintain the timely submission of expedited reports.
• Oversee the work of the CRO’s in order to ensure compliance with national and international
regulations and requirements.
• Support the achievement of the Therapeutic Area’s case processing performance timelines.
• Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk
assessment, initiate the unblinding process (as appropriate), and make the report available for
distribution.
• Identify and evaluate safety signals based on individual cases and cumulative data assessment
and by using other signal detection systems. Provide data-driven decisions and communicate
these findings proactively and effectively to the clinical team.
• Actively participate in Risk Management Committees and other risk management activities for
assigned therapeutic areas. Perform product safety reviews as appropriate.
• Provide medical input, review and analysis of Periodic Safety Update Reports, Expert
Statements, Risk Management Plans, and other aggregate reports; where appropriate, draft
components of these reports. Ensure accurate, relevant, and meaningful ICSR data and insights.
• Provide medical safety input as appropriate to Clinical Development Teams regarding
expectedness/listedness/labeledness, causality, and data reconciliation.
• As appropriate, provide medical safety input, and review or draft sections of response
documents to health authority inquiries.
•Hands-on competence in developing Risk Management Plans for high-profile drugs
Reckitt Benckiser Pharmaceuticals Richmond, VA
Drug Safety Physician Apr-2010- Dec-2011
• Reviewed and assessed all serious adverse events(SAEs) cases and adverse event reports of
Oncology especially Erbitux, Sprycel and Ixempra from all sources (clinical trials and
spontaneous).
• Responsibilities include generating Periodic Safety Update Reports (PSURs), Periodic Adverse
Drug Experience Reports (PADERs), EU CTD Annual Safety Reports, and Semi-Annual line-
listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for submission to world-
wide regulatory agencies.
• Responding to Ad Hoc Queries posed by Global Regulatory Health Authorities.
• Actively involved in updating the PSUR Template and Standard Operating Procedure
documents.
• Wrote medical case narratives and provided appropriate terminology for coding of
adverse events and other medical information in accordance with company SOPs.
• Interacted with health care professionals to obtain follow-up information pertaining to reported
SAEs.
• Identify and evaluate safety signals based on individual cases and cumulative data assessment
and by using other signal detection systems. Provide data-driven decisions and communicate
these findings proactively and effectively to the clinical team.
•Hands-on competence in developing Risk Management Plans for high-profile drugs
Ingenix Somerset, NJ
Drug Safety Physician Jan- 2009- Mar-2010
• Reviewed and assessed all serious adverse events(SAEs) cases, adverse event reports of
Oncology, GI and OTC products from all sources (clinical trials and spontaneous).
• Interacted with health care professionals to obtain follow-up information pertaining to reported
SAEs.
• Participated in preparation and drafting of ad-hoc and aggregate regulatory reports (NDA) and
labeling support documents
• Assuring compliance for pre-marketed and post-marketed annual and periodic reports.
• Coordinates and approves yearly training programs for Drug Safety personnel.
• Strategically outsource and manage assignments for drug safety functions including budgetary
details
• Maintain and creatively improve the ways of doing things including development of proactive
safety strategies and early signal detection.
• Providing direction for developing and revising local processes, procedures, and SOPs
pertaining to safety issues. Providing direction for developing and revising local processes,
procedures, and SOPs pertaining to safety issues.
•Hands-on competence in developing Risk Management Plans for high-profile drugs
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