Pharmacovigilance Specialist
On behalf of my client, a global pharmaceutical company, we have a new job for a Pharmacovigilance Specialist to join the Dublin team.
Your role:
To support the Global Pharmacovigilance Team with but not limited to the Safety Data Exchange Agreements management, Quality Management System related activities, service provider management (case processing / Art 57 – XEVMPD) and Pharmacovigilance System Master File maintenance.
Key Responsibilities:
Support the Global PV team with PV agreements management (Safety Data Exchange Agreements), updates and implementation.
Support the Global PV team in overseeing the pharmacovigilance activities performed by company Healthcare’s affiliates, and the national pharmacovigilance contact persons where applicable. Coordination of Medical Information activities with the support of the Medical Affairs team and standardization of practices across the organization.
Support the Global PV team with quality management related activities including but not limited to training, procedural documents updates, deviations management, CAPAs implementation arising from pharmacovigilance-related audits and inspections.
Support the Global PV team with the maintenance of the validation status of the global PV database, management of the Global PV database service provider.
Support the Global PV team with the maintenance of the Pharmacovigilance System Master File, including liaison with the stakeholders to ensure the data are collected in a timely manner and in high quality.
Experience & Qualifications:
Degree in Life Sciences.
Minimum 3 years Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization.
Understands and maintains 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.
For full details contact Tina on +353 1 2784701 or email your CV to [email protected]
Thornshaw scientific is a division of the CPL Group, www.thornshaw.com
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