Pharmacovigilance Administrative Assistant

Pharmacovigilance Assistant IICON 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 Administrative Assistant to join our diverse and dynamic team. As part of the Pharmacovigilance team at ICON you will play a vital role in providing administrative support on global projects. Your attention to detail will be essential in supporting the organization’s commitment to patient safety and compliance. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and to maintain the highest standards of patient safety.The role is Hybrid in Sofia, Bulgaria or Warsaw, Poland - office-based 60%, home-based 40%.Job Function/ResponsibilitiesWhat You Will Be Doing:Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processesProvide administrative support to project teams as requiredDistribute safety reports to Sponsors, sites, and applicable ICON personnel in accordance with Standard Operating Procedures and Project Specific ProceduresCoordinate setup of required systems and mailboxes during study startup (mailboxes, distribution lists, shared drives, tracking tools, etc.)File all documents within allotted timeframes, including maintenance of project mailboxes and maintenance of TMF and E-TMF, including performing quality control checksMaintain data entry for safety event and miscellaneous tracking logs for all current projectsAssist with organization and planning of meetings (room planning, set-up, and attendee logistics), including preparation and distribution of presentations, agendas, and meeting minutes, as requested.Daily entry into, and maintenance of, appropriate tracking systems (e.g. SAE/safety event tracking systems)Maintain project training records for all assigned project team membersHandle Safety Reporting courier submissions to Competent Authorities and Ethics Committees and acknowledges receipt in Safety Reporting SystemUpdating and maintenance of project database information systemsPerform regular testing of fax numbers and e-mail addresses as requiredMaintenance, coordination and updates of shared and validated documentation repositoriesCoordination of translation of documents for projectsCompletion of monthly metricsHandling requests for literature and articlesAssistance with audit schedules and arrangement, including preparation of documentsAssist with generation/distribution of project specific proceduresSupport QPPV, including PSMF activities as requiredAttend project team and Sponsor meetings and teleconferences as requiredAble to lead and mentor other team members (more Senior Admin roles).Your Profile:This position primarily involves administrative responsibilities. If you have experience in office administration, customer service, or assisting roles, we welcome your application.A background in medical or biological sciences is not required — what’s most important are strong organizational skills, keen attention to detail, and a readiness to learn.Many individuals with administrative experience find great success and satisfaction in this role.Bachelor’s degree in life sciences, pharmacy, or a related field or equivalent experience in an administrative role (any industry).Basic understanding of pharmacovigilance principles and regulatory requirements is advantageous but not essential (for PV Assistant I) / Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment (for more senior levels).Strong attention to detail and organizational skills, with the ability to manage multiple tasks efficiently.Effective communication and collaboration skills, with a focus on maintaining accuracy in documentation and reporting.Ability to work in a fast-paced, regulated environment, ensuring compliance with safety guidelines and protocols.Excellent computer skills (Microsoft Word, Excel, Outlook, PowerPoint)Fluent in written and verbal EnglishAbility to work effectively independently and within a team environment and across global teams.What ICON Can Offer YouOur 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 hereInterested 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