Drug Safety Associate

2 weeks ago

Newcastle upon Tyne, United Kingdom wax. Full time

The Drug Safety Associate plays a crucial role in ensuring the safety and compliance of pharmaceutical products throughout their lifecycle. This position involves managing pharmacovigilance (PV) vendor contracts, conducting quality control processes for PV and risk management training trackers, and supporting post-marketing reconciliation activities. The role also includes maintaining partner lists, collating metrics for quality committee meetings, and supporting PV report generation. Additionally, the specialist assists with clinical trials document management, oversees data collection programs, and supports PV quality systems management. Strong organizational skills, attention to detail, and proficiency in communication and collaboration are essential for success in this role.


Please note that this individual will be employed on a 12 month FTC. This position can be remote in either the UK or ROI, or a hybrid position based out of our client's office in Buckinghamshire.


Responsibilities:

  1. Manage PV vendor contracts and ensure compliance with safety regulations.
  2. Conduct quality control processes for PV and risk management training trackers.
  3. Support post-marketing reconciliation activities and PV report generation.
  4. Maintain partner lists and ensure alignment with PV training trackers.
  5. Collate metrics for quality committee meetings and other governance forums.
  6. Assist with clinical trials document management and update PSMF annexes.
  7. Support oversight of data collection programs and PV quality systems management.
  8. Ensure inspection-ready documentation and timely submission of regulatory packs.
  9. Liaise with clinical trial vendors for PV document transfer and submission tracking.
  10. Support review of clinical trial and post-marketing safety plans.
  11. Perform ad hoc administrative tasks and quality checks as required.


Requirements:

  • Bachelor's degree in life sciences or related field preferred.
  • Demonstrable experience in pharmacovigilance operations.
  • Strong organizational skills and attention to detail.
  • Excellent verbal and written communication skills.
  • Proficiency in Microsoft Word, Excel, PowerPoint, and SharePoint.
  • Ability to work effectively in a team environment.
  • Intellectual curiosity and passion for patient-focused healthcare.


We'd love to hear from you - to register your interest, please simply submit your CV

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