ICON plc Pharmacovigilance Assistant Role – Apply Online
Pharmacovigilance Assistant I
Location: Chennai, Trivandrum
Job ID: JR125416
Department: Drug Safety ICON Full Service & Corporate Support Office Based
About the Role
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.
Key Responsibilities:
- 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 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 acknowledgment uploads to the 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 acknowledgment of receipt (AoR) tracking in the 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. Supports and processes purchase orders and project invoices.
- Acts as gatekeeper for eTMF and project file and maintains project-specific email distribution lists.
- Uploads and files all documents within the 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 training and tracking training compliance as applicable in the relevant system(s).
- Maintenance, coordination, and access to 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.
For a detailed job description and to apply, please visit the original notification here.
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