Medical Data Entry

JULIET PEREIRA

****, *** **, *********, ** *****

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(917)435–5620, Email: **************@*****.***

OBJECTIVE

Candidate with 3 years of Pharmacovigilance experience, as a Drug Safety Specialist, for both

clinical/post marketing studies in the pharmaceutical industry and OTC pharmaceutical drugs. Seeking a

similar position working in a fast paced & timeline driven environment demanding strong organizational,

leadership, technical and interpersonal skills.

HIGHLIGHTS OF QUALIFICATIONS

• Knowledge of relevant FDA, EU, ICH guidelines and extensive knowledge of medical terminology and

principles of clinical assessment of adverse events.

• Expertise in MedDRA and WHO Drug dictionaries with relevance to AE/SAE coding.

• Outstanding communication skills (verbal and written), and Strong Narrative writing and query formation

skills.

Strong analytic and critical thinking skills and leadership/mentor/management skills.

Strong Presentation skills and attention to detail.

KEY ACCOMPLISHMENTS

• Monitored research as per Good Clinical Practices

• Periodic documentation of the ICF process for each study subject

• Protocol followed for Online data collection, surveys and feedbacks

• EDC/Coding systems – Advent, Agile, Master Control, MedWatch, InForm EDC, Medidata RAVE EDC,

Oracle Clinical, Web Portal, Microsoft Office

EDUCATION

• New York Institute of Technology – New York, NY 2012

M.B.A – Health Administration

• University of Mumbai – Mumbai, India 2007

B.Pharm – Bachelors of Pharmacy

EMPLOYMENT HISTORY

08/2012 07/2013

PL Developments – Westbury, NY

Drug Safety Specialist

• To record and monitor consumer complaints in Master Control/Agile and hand off the information to

initiate an investigation

• To provide a written response to the consumer providing pharmacovigilance at the consumer level as

needed

• Work and assist Medical advisors as needed basis

• To generate a MedWatch report as a result of an adverse event

• To answer consumer’s technical questions related to the product

• To review product labeling as needed for compliance to the CFR

• Assist the Corporate Director of Compliance or his or her delegates as required

• To provide pharmacovigilance knowledge as required

• Assist in other functions in the Department on as needed basis

09/2011 02/2012

Humanity Health, LLC – New York, NY

Clinical Research Coordinator

Therapeutic Experience Type II Diabetes (AstraZeneca), Chronic Kidney Disease (Reata

Pharmaceutical), COPD and other Respiratory diseases (Forest Research Institute).

• Provided oversight for human research studies.

• Monitoring, and follow up care of patients participating in clinical trials.

• Conduct patient visits, including scheduling, delivery of oral and written ICF, completion of subject

assessments, vital signs, ECG collection, collection of biological samples (e.g. blood, saliva, urine).

• Perform data collection in a manner that is consistent with Standard Operating procedures, Clinical Trial

protocols as well as Good Clinical Practices.

• Comfortable with set up and execution of ECG's running on the ERT system.

• Monitor for adverse events and concomitant medications of subjects participating

• Investigational drug receipt, accountability and dispensing

• Maintenance and creation of study related documents including screening and enrollment logs, drug

accountability logs, subject identification logs, and source documents.

07/2007 01/2009

Tata Consultancy Service – India

Drug Safety / Pharmacovigilance Associate

• Ensured Triage of incoming cases by determining the seriousness and prioritizing case processing

according to the time frames stated in SOP as per the company and regulatory requirements.

• Performed data entry using ADVENT safety database from the source document

• Consistently coded serious adverse events using MedDRA and medications using WHO in accordance

to project specific coding conventions in the safety database

• Communicated via phone/fax/email with physicians, study coordinators, consumers, care givers and

other parties reporting adverse events to obtain all relevant safety information

• Wrote medical evaluations including narratives and processed follow up information from the

investigational sites

• Reviewed CRFs for data issues and inconsistencies

• Tracked and logged serious adverse events (SAE's) received from Investigator sites

• Generated queries from SAE report forms in order to avoid any discrepancies

• In depth knowledge of SAE reporting

• Participated in peer review of cases during daily rounds

• Participated in weekly team meetings and teleconferences

• Train new PV Specialists via presentation and evaluation, and consistently mentored them throughout

their training period.

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CERTIFICATIONS

• National Institute of Health (NIH) 09/23/2011

• IATA (Handling, Packaging, and Shipping Infectious Substances 09/30/2011

• Customer First Culture (Stony Brook University) 2013

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