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Local Qualified Person For Pharmacovigilance In Poland

4+ years
Not Disclosed
10 Feb. 5, 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

Job Title: Local Qualified Person for Pharmacovigilance (LQP) – Poland

Employer: IQVIA
Location: Warsaw, Poland
Salary: Competitive
Start Date: 7 Jan 2025
Closing Date: 4 Feb 2025


Job Overview

IQVIA is seeking a Local Qualified Person (QP) for Pharmacovigilance in Poland to act as the local QP for customers requiring these services for their products. The role involves regulatory compliance, safety monitoring, and direct communication with Competent Authorities to ensure pharmacovigilance obligations are met.


Key Responsibilities

  • Act as the Local QP in accordance with IQVIA Lifecycle Safety Regulatory Intelligence Database (RID) requirements.
  • Available 24/7 to receive calls from the local Competent Authority and serve as the primary contact for pharmacovigilance inspections.
  • Respond to Competent Authorities’ requests regarding benefit-risk evaluations, sales data, prescriptions, and post-authorization safety studies.
  • Ensure personal details are registered with the Competent Authority upon contract commencement.
  • Stay up to date with local regulatory changes and ensure compliance with risk management plans.
  • Manage project scope (SOW) and budget, maintaining essential project materials such as files, templates, and databases.
  • Provide regular reports on project metrics, scope changes, and customer concerns to the Project Manager.
  • Communicate monthly updates to the EU QPPV/designee and submit regulatory reports as required.

Qualifications & Experience Required

  • Bachelor’s degree in Life Sciences, Medicine, Pharmacy, or Nursing (or equivalent).
  • Minimum 4 years of relevant clinical experience, including exposure to clinical trial safety and post-marketing safety.
  • Fluent in Polish (C2 level) and English.
  • Resident in Poland.

Required Knowledge, Skills & Abilities

  • Strong understanding of global, regional, and local regulatory requirements and ICH guidelines.
  • Expert knowledge of Polish pharmacovigilance regulations and relevant SOPs.
  • Excellent communication skills (written and verbal).
  • Strong analytical and problem-solving abilities for interpreting safety reports, literature, and regulatory inspections.
  • Organizational and project management skills to handle multiple pharmacovigilance responsibilities.
  • Ability to maintain oversight of product safety profiles and benefit-risk assessments.
  • Familiarity with compliance and quality management systems.

Additional Requirements

  • 24/7 availability by phone for Competent Authority inquiries.
  • Must be a legal resident of Poland.

About IQVIA

IQVIA is a global leader in clinical research services, healthcare intelligence, and life sciences. We accelerate medical innovation by providing advanced data solutions, analytics, and commercialization strategies to improve patient outcomes worldwide.

🔗 Learn more & apply: IQVIA Careers