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ICON Pharmacovigilance Assistant I job vacancy @CHENNAI
Pharmacovigilance Assistant I
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
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.
• Case tracker management and support
• 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 EudraVigilance acknowledgement of receipt (AoR) tracking in Safety Reporting System.
• 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.
• 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.
• Updates project metrics and team members in applicable systems.
• Perform other activities as identified and requested by management.
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