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Clinical Research Associate Job

Eingestellt von Yoh

Gesuchte Skills: Marketing, Client

Projektbeschreibung

Yoh has a contract opportunity for a CLINICAL RESEARCH ASSOCIATE II to join our client in Princeton, NJ.

JOB OVERVIEW:

The Pharmacoviglance Specialist/Sr. Pharmacovigilance Specialist is responsible for the processing of adverse event information from all sources including clinical trials, post-marketing and published literature. This individual will also be responsible for the preparation of aggregate reports including PSURs, ASRs, DSURs and US Periodic Reports. Additionally, he/she will serve as pharmacovigilance resource to Clinical Development Teams.

JOB RESPONSIBILITIES:

- Collect and process incoming adverse event reports from all sources
- Perform initial assessment of seriousness, expectedness, causality, and reportability
- Complete and QC data entry of incoming reports
- Identify missing or discrepant information and perform active follow-up
- Prepare expedited reports for submission to regulatory authorities and ethics committees
- Serve as pharmacovigilance resource to Clinical Development Teams
- Collaborate with clinical development staff on technical and scientific issues regarding SAE and SUSAR reporting
- Work closely with safety physicians
- Coordinate and prepare aggregate reports
- Serve as aggregate report owner with overall responsibility for completeness and consistency in conjunction with PV Physician

JOB QUALIFICATIONS:

- RN, NP OR PHARMD DEGREE WITH CLINICAL EXPERIENCE IS A MUST
- Minimum of two (2) years of pharmaceutical/biotechnology industry experience in PV including both clinical trial and post-marketing experience
- Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines
- Working knowledge of MedDRA coding
- Understanding of pharmacovigilance -related information systems
- Experience with the preparation and submission of regulatory reports
- Experience working in electronic document management systems

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Rene Borst

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading workforce solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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Ref:

SFSF: HC

Projektdetails

  • Einsatzort:

    Princeton, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh