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Local Safety Officer – Bulgaria

1-2 years
Not Disclosed
10 Feb. 10, 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

Local Safety Officer – Bulgaria (Freelance, Dedicated to One Client)

Excelya | Freelance | Bulgaria

Excelya is seeking a Local Safety Officer (LSO) to join our Pharmacovigilance team in Bulgaria. This freelance position is dedicated to one client, ensuring compliance with local and global PV regulations. The LSO will act as the local QPPV equivalent, serving as the primary pharmacovigilance contact for Health Authorities.

Key Responsibilities

  • Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV).
  • Ensure local pharmacovigilance information is updated in the Pharmacovigilance System Master File (PSMF).
  • Implement and maintain a pharmacovigilance system for the client’s authorized products in Bulgaria.
  • Collaborate with corporate Patient Safety teams to meet compliance requirements.
  • Manage SOPs, Associated Instructions (AIs), and other documents for local PV operations.
  • Oversee local service providers ensuring quality and regulatory compliance.
  • Define and track Corrective and Preventive Actions (CAPAs) for risk mitigation.
  • Assess Patient Support Programs (PSP), Market Research Programs (MRP), and Digital Initiatives for pharmacovigilance risks.
  • Monitor and communicate local regulatory changes and emerging regulations to global teams.
  • Ensure inspection readiness and support regulatory audits.
  • Act as a local Subject Matter Expert (SME) for product safety and risk management.
  • Train affiliate staff managing safety activities.

Minimum Requirements

  • Bachelor’s degree in Life Sciences (Medicine, Pharmacy, Nursing, or related fields).
  • 3-5 years of experience in Pharmacovigilance (CNS and/or Immunology therapeutic areas preferred).
  • Expert knowledge of pharmacovigilance regulations and compliance.
  • Strong leadership and influencing skills in a matrix organization.
  • Ability to analyze trends, identify gaps, and implement risk mitigation strategies.
  • Fluent in English (additional local language skills are a plus).

Why Join Us?

  • Competitive compensation and freelance flexibility.
  • Work with global industry leaders in pharmacovigilance.
  • Gain experience in regulatory compliance and safety management.