i3 Drug Safety provides comprehensive pharmacoepidemiology and pharmacovigilance services. Rooted in scientific rigor, using innovative methods and proven expertise, i3 Drug Safety's services can be customized for all scopes of work, from safety surveillance and risk assessment in clinical development to post-approval pharmacovigilance. As a UnitedHealth Group company, i3 Drug Safety is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Drug Safety can provide.
We are currently recruiting for a Pharmacovigilence Coordinator - Regulatory Authority Submissions to work in our Ann Arbor, MI office.
The Pharmacovigilance Coordinator is responsible for submission of safety reports to relevant regulatory authorities. The Coordinator will also assist with the maintenance of systems to ensure compliance with reporting requirements and submission tracking.
Responsibilities
- Perform submissions of safety reports to regulatory authorities
- Assist with the maintenance of systems to ensure compliance with reporting requirements and submission tracking
- Assist with preparation of safety reports including Periodic Safety Update Reports and FDA Periodic Reports for marketed products, as well as Annual Safety Reports for investigational products
- Attend project team meetings
- Develop and maintain a working knowledge of assigned projects and all applicable regulations
- Ensure compliance with company policies, procedures and standards
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