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Drug Safety Officer – Bulgaria

Excelya
Excelya
3-5 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: PhD/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 – Bulgaria (Freelance, Part-Time)

Excelya | Freelance | Part-Time | Sofia, Bulgaria

Excelya, a leading European CRO, is looking for a freelance Drug Safety Officer for a part-time role based in Sofia, Bulgaria. Join our 900+ experts in delivering high-quality pharmacovigilance solutions and ensuring regulatory compliance in drug safety.

Key Responsibilities

  • Maintain a functional connection with the EEA QPPV, participating in Local Safety Officer (LSO) meetings.
  • Implement and maintain a pharmacovigilance system for client products in Bulgaria.
  • Ensure regulatory compliance and oversee local pharmacovigilance deliverables.
  • Maintain quality management systems (QMS) related to pharmacovigilance, including SOPs and risk assessments.
  • Define corrective and preventive actions (CAPAs) and perform trend analysis.
  • Assess Patient Support Programs (PSPs), Market Research Programs (MRPs), and digital initiatives for pharmacovigilance compliance.
  • Monitor regulatory intelligence to track and communicate evolving pharmacovigilance regulations.
  • Act as a local subject matter expert, supporting product lifecycle activities such as risk management, recalls, and safety communications.
  • Ensure audit readiness and collaborate with corporate Patient Safety and Quality Assurance teams.

Required Skills & Qualifications

  • Bachelor’s degree in Life Sciences (Pharmacy, Medicine, Nursing, or related fields).
  • 3-5 years of experience in Pharmacovigilance, preferably in CNS and Immunology therapeutic areas.
  • Expert knowledge of pharmacovigilance regulations and requirements.
  • Strong leadership, adaptability, and interpersonal skills.
  • Ability to motivate and influence within a matrix organization.
  • High level of integrity, honesty, and ethical standards.
  • Excellent verbal and written communication skills.
  • Fluency in English and Bulgarian (written & spoken).

This is a great opportunity for an experienced Drug Safety professional to work in a flexible, high-impact role within a leading CRO.