Job Summary
This is a role for an experienced Medical Safety Specialist to support clinical trial activities by ensuring robust safety oversight processes across all study phases.
Responsibilities
* Establish and maintain effective vigilance and pharmacovigilance processes.
* Collaborate with study teams in processing adverse events and device deficiency reports accurately and timely.
Requirements
The successful candidate will have a degree in a medical, clinical, scientific, or related field and prior experience in clinical studies and knowledge of Good Clinical Practice (ICH GCP and ISO14155). Strong project management, organizational skills, and proficiency in basic software packages are also required. Excellent written and verbal communication skills in English are necessary for this role.
A strong understanding of regulatory requirements and industry standards is essential for success in this position. The ability to work effectively in a team environment and prioritize multiple tasks and projects is also crucial.