Deepa S. Patel

acfzyq@r.postjobfree.com

732-***-****

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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