Description
To provide Drug Safety support to UK marketing programs and UK patient-support programs to help ensure they compliance with regulatory requirements for the collecting and reporting of adverse event reports.
1. Provide guidance and information to Program owner on the requirements for collecting adverse event (AE) reports and the internal processes for tracking and review of new Programs.
2. Prepare and deliver training materials on AE reporting, and deliver AE training to new Marketing staff and if needed, to 3rd party vendors. Develop training materials to educate/support Program Owners on the processes for tracking and review of Programs.
3. Review initial assessment of likelihood of AE reports being received for new marketing Programs.
4. Manage the 1-month and 6-month review process of AE reporting risk for newly launched Programs.
5. Maintain oversight of Program compliance with procedures for tracking and monitoring of Marketing Programs.
Key Performance Indicators;
Initial, 1-month and 6-month assessments of Programs completed within specified timelines
All new Marketing staff trained within specified timelines
Monthly Program compliance reports generated within specified timelines
Ideal Background;
Life science degree. Other Postgraduate qualifications an advantage.
Minimum five years experience in pharmaceutical, health care or medical research sectors, including at least 2 years of project management or coordination experience
Prior experience of working in a pharmacovigilance environment is an advantage.
hy-phen Limited is acting as an Employment Business in relation to this vacancy.