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7+ years
Not Disclosed
10 May 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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