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Drug Safety Specialist

Employer
Parexel
Location
Uxbridge, United Kingdom
Salary
Competitive
Start date
17 Oct 2019
Closing date
15 Nov 2019

View more

Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

  • Quality control of case reports, line listings, and tabulations.
  • Perform literature searches.
  • Develop Expedited Reporting Procedures.
  • Maintain local drug safety reporting requirements.
  • Provide advice in regulatory affairs.
  • Perform registration with relevant authorities for electronic reporting on behalf of sponsor.
  • Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy).
  • Submission of periodic safety reports (i.e. DSUR, ASR)
  • Submission of safety reports to investigators via ISIS (International Safety.Information System)
  • Measure investigative site performance in conducting required tasks in ISIS.
  • Tracking and filing of submission cases as required.
  • Unblinding of SUSARs, as required.
  • Collect and review metrics for measuring reporting compliance.
  • Work with Global PV Information Office for collection and organization of global PV requirements.


Qualifications

  • Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification/work experience
  • Associates/diploma in any of the above with appropriate work experience.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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