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Drug Safety Officer – Hungary

Excelya
Excelya
2+ years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Description: Local Pharmacovigilance (PV) Contact – Austria & Switzerland

Responsibilities

Pharmacovigilance Leadership & Compliance

  • Serve as the local PV contact for Austria and Switzerland.
  • Act as the Responsible Person for Pharmacovigilance (RPP/QPPV) for CHC products, as required by national regulations.
  • Designate a back-up representative to ensure PV responsibilities are covered during absences.
  • Lead all PV-related activities at the country level, including:
    • Case management
    • Local safety surveillance
    • Signal detection
    • Risk management and mitigation
    • PV aspects of patient support programs and market research programs
  • Ensure all local PV activities comply with:
    • Global PV policies
    • International, regional, and local PV regulations
  • Establish and maintain robust and efficient local PV systems by:
    • Implementing proper procedures, tools, and training
    • Supporting the QPPV in overseeing PV activities in the country

Strategic & Cross-Functional Collaboration

  • Support the CHC Head of Safety with local budget planning and management.
  • Build strong collaborations with in-country Medical, Regulatory, Quality, Commercial, Legal, and Country Manager functions.
  • Act as Deputy Country Safety Head (CSH) for a partner country.

Minimum Requirements

Experience & Expertise

  • Minimum 2 years of experience in:
    • Pharmacovigilance/clinical development
    • PV systems and safety-related product management
  • Relevant experience in Regulatory Agency interactions.

Educational Background

  • Preferred degrees:
    • Medical Doctor (MD)
    • Pharmacist, PharmD
    • Veterinary Doctor
    • Health Sciences PhD, MPh, or Master’s Degree

Skills & Knowledge

  • Strong knowledge of national and international PV regulations and industry standards.
  • Problem-solving mindset with a pragmatic and solution-oriented approach.
  • Ability to prioritize, take initiative, and handle challenges effectively.
  • Fluent written and verbal communication skills in English and local language.
  • Very good proficiency in German is a mandatory requirement.