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11 days ago
Qualitair
Salary: Negotiable
Location: Maidenhead
Job type: Contract
Contact: Fabienne Basquille
Category: Medical Secretary Jobs

Based in Maidenhead, our client would like you to work on a fulltime basis, Monday to Friday. You will have the opportunity to be responsible for:

  • Receipt and processing of incoming safety information from multiple sources.
  • Entry of relevant safety data into the Global Safety Database.
  • Entry of relevant safety information to marketing partners/Global Medical safety.
  • Assist with assessment of incoming information from multiple sources.
  • Assist in quality review of data captured in the Global Safety Database.
  • Continual monitoring and assessment of reports of Individual Case Safety Reports for regulatory reporting to the Competent Authorities and notified bodies within required regulatory timelines.
  • Root cause analysis and documentation of Corrective and Preventive Actions (CAPAs).
  • Report adverse events and complaints in a timely way to Drug Safety according to current Adverse Event Reporting guidelines/SOP and to maintain regulatory compliance Acts in accordance with the company if interacting with Health case Professionals.

Experience and skills:

  • Complete annual Drug Safety and HCBI Awareness Training.
  • HCBI requirements when interacting with Healthcare Professionals and report adverse events and complains
  • Complies with designated SOPS's for the role.
  • Awareness of principles of drug development and pharmacology.
  • Proficiency in global and local SOP's,
  • Understanding of key legislation applicable to pharmacovigilance in UK and Ireland.

If you feel you have the right experience and skills for this role, and would be interested in applying, please click apply, making sure to send an up to date CV, ensuring your up to date contact details are also on your CV. We will make sure to contact you as soon as we hear back from our client to discuss the job role further.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.

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