Cache of job #14096986

Job Title

Senior QA Pharmacovigilance Compliance O

Employer

CPL

Location

GALWAY

Description

On behalf of my client, a Galway based pharmaceutical company, I am recruiting for a Senior QA Pharmacovigilance Compliance Officer. This a permanent role with an expanding company. In this role you will be responsible for the following: Work closely with the Qualified Person Responsible for Pharmacovigilance (QPPV) and other members of the pharmacovigilance team / service providers, to ensure timely, effective and appropriate processing and evaluation of Audit Reports. Review documents and reports necessary to maintain a compliant QA pharmacovigilance system. Contribute to the implementation of process / system improvements and updates to QA PV system. Liaising with and provide PV guidance & advice on QA PV topics to all key stakeholders. Identify, develop and roll-out opportunities for continuous improvement in the PV system. Work with stakeholders to ensure goals of the QA PV process are achieved. Prepare, maintaining and present PV Key Performance Indicators (KPI’s. Review of Pharmacovigilance System Master File (PSMF) and associated annexes. Participate in the preparation and roll out of Quality PV policies, guidelines and procedures. Attend PV audits / inspections and meetings, as necessary. Monitor company/ co-partner compliance and liaising with management to mitigate identified risks. Establish key performance indicators (KPIs) to monitor the effectiveness and implementation of its PV systems and processes, including areas of delegation to third-party service providers and business partners. Manage timelines for responses to PV queries from all stakeholders and customers. Supporting all PV outsourced activities. Manage & oversee PV variation changes and updates, transfer of PV information to other internal departments, PV SOP’s and PV training. Participate with inter-departments PV discussions as required. Applications are invited from candidates with the following background and experience: Minimum 3 years in a PV environment. Third level degree in relevant scientific or PhV discipline. Ability to work on multiple projects simultaneously, while maintaining excellent oral, written and presentation / communication skills. Experience in busy problem-solving environment with the ability to work to tight deadlines Excellent PV knowledge for generic products, processes and worldwide PV guidelines. Highly motivated person, with the ability to manage deadlines, work effectively as part of a multi-disciplinary team and ability to work unsupervised and on own initiative. Good IT and computer skills. For a full Job Spec and to apply for this role please call Deirdre on +353 1 2784671 or e-mail dbolger@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671.

Date Added

1525 days ago

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