Pharmacovigilance Scientist In Dublin, Ireland

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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