Senior Pharmacovigilance Intelligence Specialist - Poland - Bulgaria - 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 Senior Pharmacovigilance Intelligence Specialist to join our diverse and dynamic team. As a Senior Pharmacovigilance Intelligence Specialist at ICON, you will play a key role in monitoring and analyzing safety data to provide actionable insights that support patient safety and regulatory compliance. You will collaborate with cross-functional teams to enhance the organization's pharmacovigilance capabilities through advanced data analytics and signal detection methodologies. **Job Description Summary** • Responsible for pharmacovigilance intelligence activities in related company systems as designated • Responsible for Pharmacovigilance intelligence related activities in stand-alone and full-service projects as designated • Supports both, Marketing Authorization Holder and safety reporting requirements for company’s pharmacovigilance and reporting services as designated. • Provides management support and oversight as designated. **Job Description** • Reviews alerts and conducts database searches to collect national regulations and guidelines relevant for Pharmacovigilance intelligence requirements as designated. • Reviews queries for assigned projects and provides recommendations on relevance and possible further actions (e.g., requirements updates) as designated. • Reviews Safety Management Plans with regard to documented country-specific regulatory requirements for reporting safety information and other Pharmacovigilance services as designated • Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations • Communicate effectively, collaborates with various parties such as project team members, agency or client contacts, builds and maintains good relationships across all functions • Supports the impact assessment process via the Risk Impact Assessment Documentation (RIAD) system as designated. • Assumes ownership and oversees the Pharmacovigilance intelligence Tracking tools (e.g. Pharmacovigilance intelligence tracker, project tracker) as designated; ensures completeness, accuracy and data integrity; suggests enhancements to gain efficiencies. • Prepares or presents status reports for different purposes (e.g. on Pharmacovigilance intelligence, regulatory documents, reviews, etc.) with data from applicable systems and trackers as per assignment to ensure management oversight. • Provides any support to Pharmacovigilance intelligence management as per assignment. • Supports Pharmacovigilance intelligence metrics and KPI are within expected compliance ranges, and that corrective actions are performed as applicable. • Generates/maintains user manuals and other instructions for Pharmacovigilance intelligence and other internal users. • Provides regulatory or technical training of department or other staff as per assignment. • Oversees Pharmacovigilance intelligence related requests from managers, including those for certified translations requiring approval. • Deputizes manager activities as designated. **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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations) 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 (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply