Drug Safety Associate\ Drug Safety Specialist Pharmacovigilance
PAREXEL International - Durham, NC

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Title: Drug Safety Associate/ Drug Safety Specialist Pharmacovigilance

Department: Pharmacovigilance

Location: USA - North Carolina - Durham

Employment Type: Full Time

Job Type: Regular

Req Number: pare-10024526

Company Profile:

PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.

Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.

Description:

Drug Safety Associate/ Drug Safety Specialist Pharmacovigilance

Do you possess drug safety pharmacovigilance experience and a thorough understanding of clinical trials? We are currently seeking recognized industry professionals to get involved with providing technical and process-related expertise to drug safety management (clinical trial and post-marketed), ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Drug Safety candidates generally interact with health care professionals to obtain and follow up reports of possible serious adverse events and enter the information into a database. They may also assist in the preparation, compilation and submission of Adverse Event Reports to the FDA and other governmental agencies as required. Drug Safety duties may also include cleaning up data from SAE reports, writing narratives, completing consistency checks and performing reconciliation

Argus safety data base expertise a plus.

GROWTH:

While most companies were busy downsizing, during 2010 PAREXEL opened two new offices and added over 800 employees!

PROMOTION:

In 2010, more than 1700 PAREXEL employees received career promotions!!

EXPERTISE:

PAREXEL's experts, who have experience across a broad range of therapeutic areas, have supported nearly all of the top 50 best-selling drugs that are on the market today.

AWARDS:

PAREXEL was named Company of the Year 2010 for the Pharmaceutical Industry in The Eighth Annual International Business Awards, the only global, all-encompassing business awards program honoring great performances in business.

PAREXEL announced that the Company had been included on the 'Best 5'Pharmaceutical' industry sublist 2010 as part of The International Association of Outsourcing Professionals® (IAOP®) annual ranking The Global Outsourcing 100.

PAREXEL was recognized as a Best 10 Outsourcing Company for the Pharmaceutical Industry as part of the Global Outsourcing 100® 2010, and also received Scrip Award for Clinical Research Team of the Year.

PAREXEL was recognized as Best Performing CRO 2009 by BioSingapore for its leadership in the Asia/Pacific region, and ranked in the Top 10 among best performing Massachusetts-based public companies in The Boston Globe 100, as well as a Top Employer (ranked by number of worldwide employees)

Keywords: sae, adverse event, case processing, manager, nurse, rn, nursing, pharmacovigilance, drug, safety, clintrace, arisg, Argus, oracle, aers, phase II, phase III, phase IV, EDC, electronic data capture, Rave, Inform, Datalabs, Impact, CTMS, ePRO, IVRS, IWRS, integration, clinical trial technology, eClinical, functional requirements, statistics, biostatistics, programming, sas, clinical, clinical research, phase IIIb, phase IV, phase IIIB/IV, project management, PM, project director, clinical trial, clinical trail, clinical study, CRO, pharmaceutical, biotechnology, biotech, medical device, oncology, clinical trials, clinical studies, project manager, implementation, client interaction, sponsor, pharma, biotech

Experience:

Education:

Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification

Associates/diploma degree in any of the above with appropriate work experience

Drug safety knowledge and experience

Experience in working in drug development and/or healthcare environment

PAREXEL International - 19 months ago - save job - block
About this company
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PAREXEL International excels in pharmaceutical development services. A top contract research organization (CRO), the firm counts among its...