Clinical Trials Expert

2 days ago


Dublin, Dublin City, Ireland The RFT Group Full time

Job Overview:

The RFT Group, a leading recruitment agency in the life sciences industry, is seeking an experienced Clinical Trials Expert to join our team. As a Pharmacovigilance Manager, you will play a crucial role in ensuring the safety of patients participating in clinical trials.

About the Job:

This is a full-time permanent hybrid role, requiring presence in the Dublin office some days per week. You will take a leadership role for all aspects of Pharmacovigilance, including signal detection, safety and benefit-risk evaluations, management of potential safety issues, evaluation of databases for safety signals, and drafting responses to regulatory inquiries on product safety issues.

Main Responsibilities:

  1. Ongoing design, implementation, and review of the Pharmacovigilance system ensuring compliance with established requirements.
  2. Obtain information for deficiencies and non-compliances within the Pharmacovigilance system.
  3. Conduct audits of the PV system and licensing partners in collaboration with the Quality team.
  4. Work closely alongside Clinical Development and Clinical Operations teams to monitor emerging safety concerns from ongoing clinical trials.
  5. Contribute to and review key trial documents pertaining to safety monitoring, e.g., Safety Management Plan.
  6. Collaborate with regulatory affairs to ensure the PV system is implemented in compliance with regulatory requirements across the EU and US.
  7. Monitor the quality of third-party PV vendors across development programs.


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