Pharmacovigilance Reporting Specialist

Pharmacovigilance Reporting Specialist - Hybrid - Sofia, Bulgaria

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Pharmacovigilance Reporting Specialist to join our diverse and dynamic team. As a Pharmacovigilance Reporting Specialist at ICON, you will be responsible for the timely and accurate preparation of pharmacovigilance reports, ensuring compliance with regulatory requirements and internal policies. Your expertise in data analysis and reporting will be crucial in supporting the organization’s commitment to drug safety and patient well-being.

The role is 60% office-based in Sofia, Bulgaria or Warsaw, Poland and requires approx. 3 days/week office presence.

What You Will Be Doing:

• Preparing and submitting comprehensive safety reports, including periodic safety update reports (PSURs) and individual case safety reports (ICSRs), in 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 to ensure compliance.
• Providing training and support to team members on pharmacovigilance reporting processes and requirements.

Your Profile:

• Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred.
• Significant (4+ years) experience in pharmacovigilance reporting or drug safety within a clinical or pharmaceutical environment.
• Project lead experience is 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 in English.

#LI-Hybrid

#LI-MK2

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply