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Pharmacovigilance Reporting Specialist

4+ years
Not Disclosed
10 May 1, 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

Pharmacovigilance Reporting Specialist – Hybrid – Sofia, Bulgaria
Employer: ICON Plc
Location: Bulgaria (Hybrid – ~60% office-based in Sofia or Warsaw)
Job Type: Full-time
Start Date: 30 April 2025
Closing Date: 30 May 2025

About ICON Plc:
ICON Plc is a global leader in healthcare intelligence and clinical research. With a strong commitment to innovation, inclusion, and excellence, we support life-changing therapies by delivering high-quality clinical development solutions. Our collaborative environment empowers professionals to shape the future of drug development and healthcare.

Role Overview:
As a Pharmacovigilance Reporting Specialist, you will play a key role in ensuring the safety and compliance of pharmaceutical products through the timely and accurate preparation of safety reports. This hybrid position requires approximately three days a week of on-site work in Sofia, Bulgaria or Warsaw, Poland.

Key Responsibilities:

  • Prepare and submit safety reports, including Periodic Safety Update Reports (PSURs) and Individual Case Safety Reports (ICSRs), in compliance with global regulatory standards.

  • Analyze pharmacovigilance data to detect safety trends and contribute to benefit-risk assessments.

  • Collaborate cross-functionally to coordinate and streamline adverse event reporting.

  • Stay abreast of evolving global pharmacovigilance regulations and best practices.

  • Provide guidance and training to colleagues on pharmacovigilance reporting procedures.

Candidate Requirements:

  • Bachelor’s degree in Life Sciences, Pharmacy, or related field (advanced degree preferred).

  • Minimum 4 years of pharmacovigilance reporting experience in clinical or pharmaceutical settings.

  • Proven project leadership experience.

  • Strong proficiency in data analysis tools and pharmacovigilance reporting systems.

  • Exceptional verbal and written English communication skills.

  • Excellent collaboration, problem-solving, and compliance-focused mindset.

Why Join ICON:

  • Competitive compensation and benefits tailored to each country.

  • Multiple annual leave entitlements.

  • Comprehensive health insurance plans.

  • Retirement planning support and financial well-being tools.

  • Global Employee Assistance Programme (LifeWorks).

  • Life assurance and optional country-specific perks (e.g., childcare vouchers, gym memberships).

  • Inclusive culture dedicated to diversity, belonging, and professional development.

Diversity & Accessibility:
ICON is proud to be an equal opportunity employer. We value diverse perspectives and strive to provide a workplace free of discrimination and harassment. Accommodations are available for candidates with disabilities throughout the application and employment process.

Apply Now:
Whether or not you meet every listed qualification, ICON encourages all interested candidates to apply. You may be the perfect fit for this or another opportunity.