EU QPPV
Employer: Thornshaw Recruitment
Location: Leinster, Ireland
Salary: Negotiable
Start Date: 15 May 2025
Closing Date: 14 June 2025
Job Overview:
On behalf of a leading consultancy in the Life Sciences industry, Thornshaw Recruitment is seeking a highly experienced and motivated Qualified Person for Pharmacovigilance (QPPV) to join their growing pharmacovigilance team. This critical role entails maintaining compliance with EU and UK regulatory frameworks, overseeing the pharmacovigilance system, and serving as the primary liaison for competent authorities across the EEA and the UK.
The company embraces a flexible working model, offering autonomy over both work hours and location from day one to support a healthy work-life balance.
Responsibilities:
Serve as the EEA QPPV in compliance with EU Directive 2001/83/EC and associated regulations
Maintain current knowledge of product safety profiles and signal detection
Oversee all pharmacovigilance (PV) activities ensuring regulatory compliance
Act as the 24/7 contact for EU and UK regulatory authorities, including the EMA
Ensure timely submission of safety reports, PSURs, RMPs, and other safety-related deliverables
Support the design and maintenance of risk management plans and post-authorization safety studies
Maintain quality systems, SOPs, and training for PV operations
Prepare for and participate in audits and regulatory inspections
Lead and support corrective and preventive actions (CAPAs) related to PV compliance
Collaborate with internal stakeholders and external partners across multiple functions
Key Requirements:
In-depth knowledge of EU and UK PV regulations and GVP guidelines
Proven experience in managing inspections and audits
Demonstrated leadership and cross-functional influence
Strong problem-solving and decision-making capabilities
Excellent communication and stakeholder management skills
Qualifications:
Degree in Life Sciences (mandatory)
Based in and currently operating within Ireland (mandatory)
Minimum of 7 years of experience in the pharmaceutical industry with a focus on pharmacovigilance
Regulatory Knowledge Should Include:
EU Directive 2001/83/EC
Regulations (EC) No. 726/2004 and 520/2012
Good Pharmacovigilance Practices (GVP)
Human Medicines Regulations 2012 (as amended)
Post-Brexit MHRA Guidance
Medical Devices Regulations (UK Statutory Instruments)
Contact:
For the full job specification, please email your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701
Company:
Thornshaw Scientific, a division of the CPL Group
Website: www.thornshaw.com
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