On behalf of my client, a global pharmaceutical company, we are working with them on a new role for a Pharmacovigilance and Clinical Quality Specialist. This is a full-time permanent role based in Dublin.
The Role & Responsibilities:
The main purpose of this cross functional position is coordinating and leading a variety of:
- Pharmacovigilance system quality activities with regards to Good Pharmacovigilance Practices (GVP) compliance.
- Clinical system quality activities with regards to Good Clinical Practices (GCP) compliance from the Sponsor and IMP Supplier role perspective.
This role will involve a close collaboration with Pharmacovigilance, Clinical Operations and Clinical Supply teams.
This role will also include collaborative work with other global departments including Supply Chain, Medical Affairs, Medical Information, Pharmacovigilance and Regulatory Affairs.
Responsibilities:
Oversight of PV and Clinical Quality management System ensuring compliance with applicable GVP and GCP regulations:
Ensure compliance of PV and Clinical Quality System to GVP and GCP/Clinical Trials regulations, guidelines.
Monitor and review systems and procedures for adherence to regulatory compliance, quality improvements, efficiency, and industry best practices.
Advise and support PV and Clinical department and other functions within the company regarding PV and Clinical regulations.
Work with PV and Clinical to drive their compliance activities with regards to GVP and GCP compliance.
What you need to apply:
- Pharmacist or Engineer with degree in Quality, Regulatory or scientific topic
- Minimum of 3 years of relevant experience in GVP, GCP Quality/Clinical Compliance areas.
- Understanding and/or working knowledge of standard PV and Clinical processes.
- In depth knowledge of GCP/GVP related regulations and pharmaceutical industry compliance practices.
- Highly organized, outcome oriented, problem-solving, self-motivated, diligent person.
- Understanding of IT systems supporting GVP and GCP activities e.g. safety database/s etc.
- Excellent written and verbal communication skills; must be able to communicate effectively regarding issues related to GCP and GVP Compliance.
- Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.
- Ability to work in an international matrix environment.
For full details and job description please email your CV to [email protected] or call Tina at +353 1 2784701/087 6811990. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
