Pharmacovigilance Expert Wanted

6 days ago

Dublin, Dublin City, Ireland beBeePharmacovigilance Full time €65,000 - €90,000

Pharmacovigilance Professional

We are seeking a Pharmacovigilance Professional to join our team in Dublin, Ireland. The successful candidate will be responsible for ensuring compliance with EU regulatory requirements.

Responsibilities:

  • Conduct signal detection activities as per the defined schedule and document all outputs produced.
  • Review and assess potential signals/new safety concerns and coordinate/document resulting actions with relevant stakeholders.
  • Contribute/coordinate/perform RMPs updates, define risk minimization measures, and ensure timely implementation, execution, and tracking.
  • Maintain up-to-date status of all RMPs and manage Regulatory Affairs' requests related to RMPs updates/submissions.
  • Contribute/coordinate aggregate safety reports preparation by healthcare service provider, ensure quality and on-time submission to regulatory authorities, partners, and affiliates.
  • Support the Global PV team in ensuring all CCDS are up-to-date and maintained/reviewed as per the applicable procedure, coordinate the CCDS review by internal stakeholders and support with the impact assessment on SmPCs/PILs.

Qualifications:

  • Degree in life sciences.
  • Minimum 5 years of experience in safety/pharmacovigilance in biotech, pharma, or clinical research organization.
  • Strong working knowledge of PV global regulations and guidelines with PV operational knowledge.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Ability to establish working relationships with people globally and locally, in various functions with a wide variety of disciplines and backgrounds.

If you have the skills and qualifications we are looking for, please submit your application.

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