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Job Details

Drug Safety Specialist

Company: ProClinical Ltd
Location: Uxbridge
Reference: DS.LE.10398
Closing Date: 23 Jan 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

A major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Drug Safety Specialist to join their team in Uxbridge, UK. This is an excellent opportunity to join an innovative company that delivers life-changing drugs with over 4,000 employees in over 50 countries worldwide. ...

Requirements:

A major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Drug Safety Specialist to join their team in Uxbridge, UK. This is an excellent opportunity to join an innovative company that delivers life-changing drugs with over 4,000 employees in over 50 countries worldwide.

Job Role:

To manage safety data within the company#s central safety database covering both pre and post market activities. To ensure compliance with internal case processing timelines.

Key Responsibilities:

  • Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerised
  • Conduct full data entry from source document
  • Execute QC on key fields of serious cases and update ARISg as needed
  • Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
  • Create narrative as defined by conventions
  • Create draft company comments for serious cases
  • Authorise (approve) non-serious cases
  • Review and resolve ARISg validation errors
  • Support the identification of corrections and creation of updates in ARISg following medical review
  • Discuss issues with medical reviewers as appropriate
  • Contribute to conventions and process documentation as required
  • Support continuous improvement of processes and safety database
  • SAE and PM non serious AE investigation needs
  • Adverse Event case report data within the central safety database
  • Case narratives for incorporation within company documents
  • Accurate and timely case safety reports for submission to regulatory agencies

Education, Skills and Experience:

  • 2 years relevant clinical experience or relevant scientific background equivalency
  • 2 years relevant experience in the Industry
  • Data entry/data management or document management experience
  • Clinical knowledge of therapeutic area patient populations and drug class
  • Computer and database skills preferred
  • Medical terminology
  • Applicable Pharmacovigilance legislation

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Lisa Edgar on +44 203 7520 313 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Drug Safety Specialist

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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