Pharmacovigilance Assistant I

• Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes
• Provide administrative support to project teams as required
• Distribute safety reports to Sponsors, sites, and applicable ICON personnel in accordance with Standard Operating Procedures and Project Specific Procedures
• Coordinate 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 checks
• Maintain data entry for safety event and miscellaneous tracking logs for all current projects
• Assist 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 members
• Handle Safety Reporting courier submissions to Competent Authorities and Ethics Committees and acknowledges receipt in Safety Reporting System
• Updating and maintenance of project database information systems
• Perform regular testing of fax numbers and e-mail addresses as required
• Maintenance, coordination and updates of shared and validated documentation repositories
• Coordination of translation of documents for projects
• Completion of monthly metrics
• Handling requests for literature and articles
• Assistance with audit schedules and arrangement, including preparation of documents
• Assist with generation/distribution of project specific procedures

• Support QPPV, including PSMF activities as required
• Attend project team and Sponsor meetings and teleconferences as required
• Able to lead and mentor other team members (more Senior Admin roles).

• 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 English
• Ability to work effectively independently and within a team environment and across global teams.

ICON