Job Summary
Thornshaw Recruitment is hiring an experienced Qualified Person for Pharmacovigilance (QPPV) to join a leading Life Sciences consultancy based in Leinster, Ireland. This high-responsibility role offers flexibility in work location and hours while ensuring oversight of pharmacovigilance systems in compliance with EU and UK regulations. Ideal for professionals with 7+ years of pharmaceutical industry experience and expertise in PV operations.
Key Responsibilities
Serve as the designated EEA QPPV under EU Directive 2001/83/EC and related pharmacovigilance regulations.
Maintain comprehensive safety profiles and proactively identify emerging product safety concerns.
Ensure timely, compliant submission of regulatory PV documents across multiple jurisdictions.
Oversee and maintain risk management plans and post-authorisation safety studies.
Act as 24/7 contact for regulatory authorities, including EMA and competent authorities in the EEA and UK.
Guarantee audit readiness through the development of robust quality systems, training programs, and documentation.
Lead resolution efforts in corrective and preventative actions within PV processes.
Influence cross-functional teams and external stakeholders to drive PV system improvements.
Required Skills & Qualifications
Bachelor’s degree in Life Sciences (mandatory).
Based and operating in Ireland (mandatory).
Minimum of 7 years’ experience in the pharmaceutical industry with substantial pharmacovigilance exposure.
In-depth knowledge of:
EU Directive 2001/83/EC
Regulations (EC) No. 726/2004 and 520/2012
GVP Guidelines
Human Medicines Regulations 2012 (as amended)
Post-Brexit MHRA Guidance
Medical Device Regulations 2002
Strong leadership and decision-making skills.
Proven success in managing PV audits and regulatory inspections.
Ability to resolve CAPA related to drug safety effectively.
Perks & Benefits
Highly flexible work environment (remote, hybrid, or office options).
Supportive company culture promoting work-life balance.
Opportunity to lead and shape the pharmacovigilance function of a dynamic consultancy.
Collaborative and trust-based team setting from day one.
Company Description
Thornshaw Recruitment, part of the CPL Group, is a premier life sciences recruitment consultancy connecting top talent with leading pharmaceutical, biotechnology, and medical device companies across Ireland and Europe. Their client offers tailored PV consultancy services ensuring regulatory compliance and patient safety.
Work Mode
Remote, Hybrid, or On-site – Leinster, Ireland
Call to Action
Are you ready to make a difference in global pharmacovigilance leadership? Apply now for this EU QPPV role and contribute to enhancing drug safety and regulatory excellence.
Note:
Salary: Not specified (Negotiable)
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