Pharmacovigilance Assistant
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
The Pharmacovigilance Assistant performs a variety of administrative tasks to support the business and the project management within Pharmacovigilance and Safety Reporting, including but not limited to:
• Distribution of incoming safety notifications
• Submitting, filing and tracking of safety related information
• Working with the business and the Project Manager to ensure that tasks and projects are completed in accordance with SOPs, Project Specific Procedures, regulatory requirements and contract and client expectations/processes
• Recognize, exemplify, and adhere to ICONs values which centers around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
Business Support:
• Receives and distributes incoming safety notifications (such as exception approvals, hospital records, SAEs, SAE Hotline calls and other safety events via eFax, e-mail and safety mailboxes) to the appropriate project teams or to Sponsor contacts as per assignment; or surveillance of Safety Reporting specific mailboxes.
• Initiates appropriate actions to protect data privacy with regards to received unrequested personal identifiers.
• Maintains data entry for SAEs and miscellaneous tracking logs for all current projects.
• Prepares and submits courier shipments and electronic safety submissions on behalf of the project teams, including acknowledgement uploads to Safety Reporting System and maintenance of address data for safety submissions.
• Mailbox Surveillance for the safety reporting group.
• Case tracker management and support .
• Approval Letters (Approval Letter Date report, Approval Letter Task, Distribution to client as per partnership).
• Distribution of safety related documents like Clinical Trial Application (CTA), Power of Attorney (PoA) or delegation documents, and website searches as support to the safety reporting intelligence team.
• Uploads documents into the electronic Trial Master File (eTMF) and tracks the status in the Safety Tracking Tools.
• Downloads Safety Reporting Post-Marketing ICSR.
• Completes MLM Searches and GCT tracking.
• Completes EudraVigilance acknowledgement of receipt (AoR) tracking in Safety Reporting System.
• Downloads and tracks MHRA AoR.
• Obtains the Safety Reporting System cover letter.
• Safety Reporting (CA Country Portal submissions, Monitoring of mailboxes and/or Client Portal, Support for expedited and periodic reporting and Bulk report submission and reconciliation)
• Performs the Translation Management Process as assigned.
• Perform regular testing of SAE Hotline, departmental phone lines, fax numbers and email addresses (general and project specific) as required; documents results.
• Maintain departmental and global calendars as required.
• Completion of monthly metrics.
• Perform offsite archiving activities as required.
• Coding of invoices and submission for approval.
• Applies knowledge and adheres to company policies and procedures including corporate guidelines and best practices. Flag errors/non-conformance to established processes.
• Applies knowledge of computerized information systems and standard application software (Windows, MS Office).
• Identifies and recognizes problems that have established precedents and limited impact. Refers non-standard questions and problems to higher levels.
Project Management Support:
• Organizes project team and client meetings including scheduling, agendas, preparation of presentations and meeting minutes.
• Organizes, reviews and manages project specific information and material following applicable company processes, (such as organizational charts, Project Management Plans, project status reports).
• Supports the Project Manager with financial tasks. Support and processes purchase orders and project invoices.
• Acts as gatekeepers for eTMF and project file and maintains project specific email distribution lists.
• Uploads and files all documents within allotted timeframe into the electronic Trial Master File (eTMF) or Trial Master File (TMF), including package preparation, reconciliation of the TMF and the safety tracking tools for inspection readiness, sampling and coherence QC and query resolution and follow up. Monitoring and filing of project specific mailboxes.
• Maintains training matrix, including assigning and tracking project specific trainings and tracks training compliance as applicable in the relevant system(s).
• Maintenance, coordination and access of project Enterprise Document and Content Management Systems (EDCMS) and mapped drives etc.
• Monitors project team’s approved Curriculum Vitae (CV) dates in eTMF or Project File for compliance with applicable SOP.
• Drafts the Monthly Executive Overview Report (MEOR) for Project Managers. Contacts Functional Team Leads for MEOR metrics. Enters MEOR sent dates in applicable systems.
• Updates project metrics and team members in applicable systems.
• Perform other activities as identified and requested by management.
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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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