Safety Manager, Device ( EU-Home Based ) - Iqvia Biotech
"Delivers Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and Novella SOPs and/or project specific procedures. Primary responsibilities include processing and reporting of incoming safety events and related data. Serves in a mentorship/leadership role, including Safety Management Lead on moderate to large sized studies/programs that are moderate to complex in scope of work. "
• . Serve as Safety Management lead on moderate to large sized studies/programs that are moderate to complex in scope of work with minimal guidance. Responsibilities include, but are not limited to: All aspects of Safety Management start-up process including writing Safety Management Plan, developing SAE form, etc. Attendance at team and client meetings Investigator's meeting attendance Presentations Training of staff on safety processes Compliance with budget, including estimating monthly budget projections. Ensures compliance with client budget and proactively escalates potential scope changes or noncompliance with cost or time allocation to department Manager May assist with bid defenses or other presentations May mentor and/or train new Safety Management staff Performs other related duties as assigned or requested by department management
• Bachelor's Degree Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required. Req
• Minimum of 3 years of experience in clinical trial safety.. Equivalent combination of relevant education and experience.. Computer literacy and experience working with Microsoft Office (Word, Excel) required . Knowledge of electronic data capture preferred.. Excellent verbal and written communication skills required. .
#LI - SS4
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