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Drug Safety Officer – Hungary

2+ years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: PhD/MPh/Pharm D/MBBS/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

Drug Safety Officer – Hungary (Full-Time, Permanent Contract)

Excelya | Full-Time | Permanent | Hungary

Excelya, a leading Contract Research Organization (CRO), is looking for a Drug Safety Officer to oversee pharmacovigilance (PV) activities in Austria and Switzerland. This role requires ensuring regulatory compliance, acting as the local PV contact, and managing safety surveillance and risk mitigation efforts.

Key Responsibilities

  • Act as the local PV contact for Austria and Switzerland, ensuring compliance with global, regional, and local PV regulations.
  • Serve as the Responsible Person for Pharmacovigilance (RPP/QPPV) where applicable.
  • Lead case management, safety surveillance, signal detection, risk mitigation, and patient support programs.
  • Ensure inspection readiness and represent the company in PV inspections.
  • Maintain a robust local PV system with effective procedures, tools, and training.
  • Support the QPPV in overseeing PV activities and ensuring compliance.
  • Assist the CHC Head of Safety in budget planning and management.
  • Build strong collaborations with cross-functional teams, including Medical, Regulatory, Quality, Commercial, Legal, and Country Managers.
  • Act as Deputy Country Safety Head (CSH) for a partner country.

Minimum Requirements

  • 2+ years of experience in pharmacovigilance, clinical development, PV systems, or safety-related product management.
  • Experience in Regulatory Agency interactions.
  • Medical Doctor (MD), Pharmacist (PharmD), Veterinary Doctor, Health Sciences PhD, MPH, or Master's degree (preferred).
  • Strong understanding of national and international PV regulations and industry standards.
  • Proactive problem-solving skills with a solution-oriented mindset.
  • Fluent English and local language skills.
  • Proficiency in German is mandatory.

This role offers a dynamic, high-responsibility opportunity to lead pharmacovigilance efforts in an international setting with a top-tier CRO.