ARPITA PATEL

**** **** ******

NORTH BERGEN, NJ 07047

PHONE: 201-***-**** E-MAIL: acf091@r.postjobfree.com

OBJECTIVE

To obtain a Drug Safety Associate position that will promote growth, stability and opportunity

for advancement.

SUMMARY OF QUALIFICATIONS

• Comprehensive knowledge of international drug safety and pharmacovigilance principles and

regulations

• Extensive knowledge of drug safety and drug development process and procedures

• Knowledge of ICH-GCP, FDA and EMA guidelines

• Knowledge of scientific terms and medical terminology

• Knowledge of database Oracle ARGUS

• Comprehensive knowledge of Clinical Trials (Phase I- IV)

• In-depth knowledge of MedDRA and WHO-drug coding

• Proficient in data entry and drug safety database

• Excellent written and verbal communication skills

• Proven interpersonal & organizational skills and analytical thinking

EDUCATION

Stevens Institute of Technology Hoboken, USA Dec 2012

Masters of Science in Pharmaceutical Manufacturing GPA: 3.7

Certification in Validation and Regulatory Affairs Dec 2012

Stevens Institute of Technology, Hoboken, NJ

Certification in Pharmaceutical Manufacturing Practices Dec 2012

Stevens Institute of Technology, Hoboken, NJ

Shri. M. N. College of Pharmacy Gujarat, India May 2004

Diploma in Pharmacy

Smt.R. B. Patel Pharmacy College Gujarat, India April 2008

Bachelor of Pharmacy

DURATION: Aug 2013-Present

ORGANIZATION: E I DuPont De Nemours and Company, Parlin NJ

DESIGNATION: Pharmacovigilance Case Associate

• Initial data entry of case reports into safety database / tracking system - Assessment of case

reports for seriousness, causality and expectedness

• Coordinated all medical services and provided oversight of the medical department.

• Responsible for patient safety and provided medical guidance for various medical monitored

programs.

• Provided recommendations on medical protocols for new products.

• Created medical protocol material and provided training to managers.

• Presented incident reports to senior management and reviewed scientific literature to address

urgent safety issues. Reviewed and interpreted medical data generated by statistical analyses.

Maintained regulatory Reports.

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Established work priorities and directions independently with minimal input from Manager.

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Collected, documents, and processed adverse event (AE) reports from clinical trials and post

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Marketing sources adhering to Standard Operating Procedures.

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Prepared clinical narrative summaries for ‘Adverse Event’.

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Performed active follow-up via telephone contact with consumers and health care

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professionals.

• Ensured timely coverage to Regulatory Authorities and pharmacist.

• Participated in preparing safety reports and maintained clinical databases.

• Identified case assessment related problems and reviewed reports.

• Identified potential product complaints.

• Performed medical coding using MedDRA and WHO-Drug dictionaries and composes case

narratives.

• Determined follow-up requirements and recommend follow-up.

• Performed effectively on assigned cases.

• Assist in preparation of reports to meet FDA/Regulatory AE summary requirements and SOP

guided protocols.

EXPERIENCE

Agnicient Edison, NJ Sep 2012- April 2013

Client: Genzyme Corporation, MA

Drug Safety Associate

• Received, documented and processed adverse event (AE) reports from clinical trials and post-

marketing in accordance with company Standard Operating Procedures (SOPs)

• Performed initial book-in and assessment of incoming reports from various sources such as

structured and unstructured

• Performed case Prioritization/Triaging based on seriousness of adverse events in accordance

with SOP guidelines

• Processed cases with an accuracy and consistency at various stages of the system workflow

• Performed manual coding of AEs using MedDRA dictionary for the events that were auto-

encoded

• Prepared clinical narrative summaries for AE reports independently from clinical studies and

spontaneous post-marketing reports

• Performed necessary follow-up for missing, discrepant or additional information from source

documentation

• Generated queries using ARGUS interface for clarification, resolving and forwarding to next

work flow

• Performed preparation of expedited and non-expedited reports to regulatory authorities to

ensure compliance with regulatory and within company time frame

• Participated in preparation of Periodic and aggregate safety reports

• Collaborated and coordinated with Data Management personnel to ensure that key data fields

are reconciled and assisted in resolving discrepancies

• Tabulated and formatted AE’s with Medwatch form for FDA regulatory reporting and familiar

working with CIOMS form for EU regulatory reporting

Process Development Scientist April 2011-Aug 2012

Stevens Pharmaceutical Research Centre, Hoboken, NJ

• Developed a process for tablet manufacturing using Design of Experiments as a part of

implementing Quality by Design (QbD) and performed Monte-Carlo Simulation to build a

robust process.

Applied Lean Six Sigma tools on validation project such as Gage Linearity and Bias, Gage R

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& R, Process capability, Statistical Process Control (SPC), Control chart and ANOVA using

Minitab 16.

During product design phase created and analyzed DOE for formulation as well as for

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manufacturing process, analytical method and cleaning procedure.

Created fishbone (Ishikawa diagram) and Risk Assessment (FMEA) for each step of process

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to determine Critical Process Parameters (CPPs) required to obtain quality product.

Based on DOE, determined design space to reduce the need for Change Control.

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Designed cleaning validation method (DOE, QbD), developed and executed protocol, reported

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deviation, performed root cause analysis, suggested corrective actions (CAPA) and generated

validation final report.

Evaluated monitoring of Clean in Place (CIP) System to perform cleaning validation using a

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combination of Conductivity and TOC analysis (GE Siever's 900).

Performed recovery studies to develop cleaning validation method of APIs using TOC

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analyzer.

Trained on Team Dynamics (Bruce Tuckman), Emotional Intelligence (Myers-Briggs) and

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Conflict Modes of Behavior (Thomas-Kilman).

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