Pharmacovigilance Assistant I

4 days ago

Chennai Tamil Nadu, India ICON Plc Full time

Pharmacovigilance Assistant I

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
- 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.
- 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.
- 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.
- 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

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