Operations Specialist 2, Regulatory Reporting

**Job Overview**
**Essential Functions**
- Assess Lifecycle Safety data for reportability to relevant authorities, including EudraVigilance, and track reportable cases.
- Report to regulatory authorities, ethics committees, institutional review boards, investigators, and oversight groups per legislation, within timelines, and in a format compatible with requirements.
- Liaise with local IQVIA offices and relevant stakeholders to facilitate expedited reporting.
- Perform quality control of safety data and ensure compliance with IQVIA high-quality standards.
- Generate status reports, provide project metrics to PVS Leads, and assist LS management with Safety Management Plan (SMP) reviews.
**Qualifications**
- Bachelor’s Degree in a scientific or healthcare discipline or allied life sciences required.
- Up to 5 years of relevant experience, including up to 3 years of Pharmacovigilance experience required.
- Advanced level of English
- In-depth knowledge an...