Drug Safety Project Lead
Eastleigh, United Kingdom
Purpose of the Role
As a Drug Safety Coordinator, you will be expected to:
- Lead projects and take on project management activities;
- Prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, and Principal Investigators and business partners;
- Ensure compliance with regulatory reporting requirements for safety reporting in clinical trials;
- Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information;
- Ensure the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors;
- Serve as support to Safety Reporting Group management in all aspects of departmental activities, as needed;
- Serve as technical expert with regard to all aspects of safety reporting.
- The successful candidate will have significant relevant clinical research/pharmaceutical industry experience, in pharmacovigilance/drug safety, with thorough knowledge of global safety processes/regulations and medical terminology/coding systems;
- Must be fluent in written and verbal English with good communication skills and basic computer skills. Detail orientated and capable of working effectively within a team environment;
- Medical/science background (nursing preferred) and/or bachelor’s degree or local equivalent.