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.
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