Safety Scientist II/ III, EMEA
Core
Manage the safety profile of new drugs in clinical trials, oversee case-processing activities, and perform regulatory reporting and medical monitoring tasks.
Role type
Mid-to-Senior Product Safety Scientist (Pharmacovigilance)
Builds
Signal detection activities, regulatory reports, and medical monitoring for clinical trial products
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Required skills
Pharmacovigilance requirements expertise, data interpretation, medical-scientific writing, critical thinking, project management, mentoring, budget forecasting, complex project administration
Preferred skills
None explicitly stated
Technologies
Microsoft Office (Outlook, Word, Excel), multiple company and client systems
Responsibilities
Plan, coordinate, and deliver signal detection and product safety scientist activities; conduct quality reviews for safety tasks; advise clients on safety issues; lead small FSP projects; support training and mentoring of junior colleagues; contribute to development of processes, tools, and systems; participate in bid defense and proposal development; ensure tasks comply with company policies and regulations; manage routine project implementation including kick-off meetings, communications, data requests, client meetings, audits, and inspections.
Seniority
Mid-level to Senior, hands-on IC with mentoring responsibilities