Manager

Job Description

·Lead or participate in cross-functional safety review teams for productsin clinical development : Active participation inmonitoring safety of products in clinical development; lead discussions incross-functional review meetings on safety issues for products in clinicaldevelopment. Collaborating with other members of the drug development team,including pharmacologists, toxicologists, and statisticians, to ensure thatsafety issues are adequately addressed. Be responsible for safety surveillanceactivities for this product including medical review of individual safety casesdirectly in the safety database and signal detection activities (ongoing reviewof safety data). Escalate and present safety issues at company safetygovernance bodies. Be a member of study teams and work in a collaborative andproactive way in a matrix environment. Participate in DMC (Data MonitoringCommittee) meetings or other safety-related interactions with outsidecollaborators, and in...