Graduate Pharmacovigilance Associate
hace 2 meses
As a Graduate Pharmacovigilance Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
**What you will be doing**:
- Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study set-up, within study specified timelines.
- Develop understanding of ICON's safety reporting systems, processes, and conventions, as appropriate.
- Develop understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting.
- Support filing activities in the eTMF ensuring file readiness on assigned projects for audits or inspections.
- Serve as safety reporting or quality complaint processor for assigned projects, providing support as designated.
- Complete adverse event and/or product quality complaint cases follow up in writing and/or by phone based on requirements for each Client.
- Supports periodic reconciliation of adverse event and/or quality complaint cases received from different sources within the required deadlines
- Monitor the process of returning samples for quality compliant and applicable tracking
**You are**:
- G-Bachelor's Level Degree
- 0-3 years of experience
**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 maximise 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
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