Pharmacovigilance Associate - Italian speaker

Pharmacovigilance Associate - Bulgaria, Poland - office or home

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 Associate to join our diverse and dynamic team at ICON. This is a hybrid role, combining standard global PV responsibilities with local PV activities, providing an exciting opportunity to work across multiple levels of pharmacovigilance while supporting compliance and patient safety.

As a Pharmacovigilance Associate at ICON, you will play a key role in monitoring the safety of pharmaceutical products, ensuring timely reporting of adverse events, and serving as the local PV contact for national competent authorities. Your attention to detail, regulatory knowledge, and proactive approach will be essential in supporting both local and global safety operations.

What You Will Be Doing:

Global PV Responsibilities

• Collect and review adverse event reports to ensure accurate and timely reporting in line with regulatory guidelines.
• Conduct signal detection and risk assessment activities to identify potential safety issues.
• Collaborate with cross-functional teams to support safety-related inquiries and investigations.
• Assist in the preparation of safety reports and regulatory submissions (e.g., DSURs, PSURs, PBRERs).
• Maintain up-to-date knowledge of global pharmacovigilance regulations and industry best practices.

Local PV Responsibilities

• Act as the official local PV contact for national competent authorities.
• Manage and respond to pharmacovigilance-related requests from health authorities.
• Conduct country-level literature surveillance.
• Perform routine tracking, status reporting, and reconciliation of adverse events.
• Maintain awareness of local legislation and regulatory requirements.
• Support and participate in PV inspections, audits, and authority interactions at the local level.
• Ensure collection, documentation, and timely reporting of all adverse events originating locally.
• Forward ICSRs to the global safety database within applicable regulatory timelines.
• Support follow-up activities with reporters, healthcare professionals, and partners as required.

Your Profile:

• Bachelor's degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred.
• Fluent in Italian and English
• Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment.
• Strong analytical skills with attention to detail in data collection, reconciliation, and reporting.
• Excellent communication and interpersonal skills, enabling effective collaboration with team members, stakeholders, and authorities.
• Understanding of both local regulatory requirements and global PV processes.
• Commitment to high standards of quality, compliance, and patient safety.

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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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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