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Pharmacovigilance Scientist In Dublin, Ireland

4 weeks ago

Dublin, Dublin City, Ireland Pharmaceuticalcarrier Full time

Job Title: Pharmacovigilance Scientist Location: Dublin, Ireland (flexible and hybrid work options available)
Our client, a pharmaceutical company based in Dublin, is seeking a Pharmacovigilance Scientist to support the Head of Pharmacovigilance/QPPV in ensuring compliance with EU regulatory requirements.
The successful candidate will be responsible for signal detection management, risk management plans, aggregate safety reports, and CCDS management/clinical safety.
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 are interested in this exciting opportunity, please email your CV to ****** or call Tina at +353 1 2784701/087 6811990 for full job specifications and details related to this role and company.
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