Scientist in Safety and Risk Management

2 days ago

Dublin, Dublin City, Ireland beBeePharmacovigilance Full time €80,000 - €100,000

Job Opportunity: Pharmacovigilance Scientist
Dublin, Ireland

Job Description

We are seeking a skilled Pharmacovigilance Scientist to join our team in Dublin. As a key member of our pharmacovigilance group, you will be responsible for ensuring compliance with EU regulatory requirements.

Your primary focus will be on signal detection management, risk management plans, aggregate safety reports, and CCDS management/clinical safety.

You will conduct signal detection activities as per the defined schedule, document all outputs produced, review and assess potential signals/new safety concerns, and coordinate/document resulting actions with relevant stakeholders.

In addition, you will contribute/coordinate/perform RMPs updates, define risk minimization measures, ensure timely implementation, execution, and tracking, maintain up-to-date status of all RMPs, and manage Regulatory Affairs' requests related to RMPs updates/submissions.

Furthermore, you will 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, and coordinate the CCDS review by internal stakeholders and support with the impact assessment on SmPCs/PILs.

Required Skills and Qualifications

To be successful in this role, you will need:

  • 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.
Benefits

This is an exciting opportunity to work in a dynamic and growing industry. You will have the chance to work with a talented team of professionals and contribute to the success of our organization.

If you are interested in this role, please apply via email or phone.

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