Job Title:
Pharmacovigilance Reporting Specialist
Company:
ICON Plc
ICON plc is a world-leading healthcare intelligence and clinical research organization, fostering an inclusive environment focused on innovation and excellence. ICON is committed to shaping the future of clinical development.
Location:
Bulgaria (Hybrid: 60% office-based in Sofia, Bulgaria or Warsaw, Poland)
Salary:
Competitive
Start Date:
30 April 2025
Closing Date:
30 May 2025
Job Description / Responsibilities:
As a Pharmacovigilance Reporting Specialist at ICON, you will be responsible for:
Preparing and submitting comprehensive safety reports, including periodic safety update reports (PSURs) and individual case safety reports (ICSRs), ensuring compliance with regulatory standards.
Conducting thorough data analysis to identify trends and assess the safety profile of pharmaceutical products.
Collaborating with cross-functional teams to ensure timely and accurate reporting of adverse events.
Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices.
Providing training and support to team members on pharmacovigilance reporting processes and requirements.
Qualifications:
Education: Bachelor's degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred.
Experience: Minimum 4+ years of experience in pharmacovigilance reporting or drug safety in a clinical or pharmaceutical environment.
Project Lead Experience required.
Strong analytical skills with proficiency in data analysis tools and reporting software.
Excellent communication and interpersonal skills, facilitating effective collaboration with internal and external stakeholders.
A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities.
Excellent command of English.
What ICON Offers:
Competitive salary and benefits.
Annual leave entitlements.
Health insurance offerings for you and your family.
Retirement planning offerings.
Global Employee Assistance Programme (LifeWorks) for well-being.
Life assurance and flexible country-specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, etc.
Additional Information:
ICON values inclusion and belonging, providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Reasonable accommodations are available for candidates with medical conditions or disabilities during the application process or job performance.
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