Senior Pharmacovigilance Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €60,000 - €90,000

Pharmacovigilance Expert Opportunity

We are seeking an experienced Pharmacovigilance Scientist to join our team in Dublin, Ireland. As a key member of our Pharmacovigilance team, you will play a crucial role in ensuring compliance with EU regulatory requirements.

About the Role:
  • You will be responsible for conducting signal detection activities and documenting all outputs produced.
  • You will review and assess potential signals/new safety concerns and coordinate/document resulting actions with relevant stakeholders.
  • You will contribute/coordinate/perform risk management plans updates, define risk minimization measures, and ensure timely implementation and tracking.
  • You will maintain up-to-date status of all risk management plans and manage Regulatory Affairs' requests related to plan updates/submissions.
  • You will contribute/coordinate aggregate safety reports preparation by healthcare service provider, ensure quality and on-time submission to regulatory authorities, partners, and affiliates.
  • You will support the Global PV team in ensuring all critical safety documents are up-to-date and maintained/reviewed as per the applicable procedure.
Requirements:
  • Degree in life sciences or a related field.
  • 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.

Benefits:

This is an excellent opportunity to work with a leading pharmaceutical company in Dublin, Ireland. Our company offers a competitive salary and benefits package, including opportunities for career growth and professional development.

What We Offer:

In addition to the above benefits, we offer a range of employee benefits, including health insurance, pension scheme, and flexible working hours.

Contact Us:

If you are interested in this exciting opportunity, please submit your application, including your CV and a cover letter, outlining your suitability for the role.

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