Pharmacovigilance Administrative Assistant

Pharmacovigilance Administrative Assistant - Blue Bell, PA (Hybrid)

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 have an incredible opportunity for a Pharmacovigilance Administrative Assistant to join ICON’s Full Service PV & Safety team. The PV Administrative Assistant will play a vital role in providing administrative support on global projects. Attention to detail will be essential in supporting the organization’s commitment to patient safety and compliance. The PVA collaborates with cross-functional teams to ensure compliance with regulatory requirements and to maintain the highest standards of patient safety.

Location: Hybrid in Blue Bell, PA (Office-Based a minimum of 3 days/week)

What you will be doing:

• 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 eTMF, 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
• Update and maintain project database information systems
• Perform regular testing of fax numbers and e-mail addresses as required
• Maintain, coordinate, and update shared and validated documentation repositories
• Coordinate translation of documents for projects and handle requests for literature and articles
• Complete monthly metrics
• Assist 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

Your profile:

• Prior experience in office administration or relatable clerical role
• Strong attention to detail and organizational skills, with the ability to manage multiple tasks efficiently with a focus on maintaining accuracy in documentation and reporting
• Communication and collaboration skills, with the ability to work independently and within a team environment and across global teams
• Ability to work in a fast-paced, regulated environment, ensuring compliance with safety guidelines and protocols
• Excellent computer skills including proficiency with Microsoft Office Suite (Word, Excel, Outlook, PowerPoint, Teams)
• Basic understanding of clinical research and/or pharmacovigilance principles and/or regulatory requirements (preferred, but not required)
• Experience with document preparation, shipping, and tracking (preferred, but not required)
• Ability to work effectively independently and within a team environment and across global teams
• Ability to work in Blue Bell, PA a minimum of 3 days per week

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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 sav