Clinical Safety Specialist
- Wilmington, NC
What you'll be doing
- The clinical safety specialist will perform day-to-day adverse event reporting and subsequent pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to: collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinate and perform adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborate with various parties such as: project team members, client contacts, investigators, and adverse event/reporters, and third party vendors. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.
What your background should be
- Minimum 2+ years of clinical experience or 1 year of pharmacovigilance experience or equivalent. Process detailed knowledge of relevant therapeutic areas as required for processing AEs. Good oral and written communication skills including paraphrasing skills. Good command of English and ability to translate information into local language where required. Computer literate with the ability to work within multiple databases.
Required Schooling / Training
- Bachelor degree in nursing, medical technology or pharmacy.
Who is the client company
- This is a niche human capital solutions and consulting firm specializing in the deployment of best-in-class services and staffing solutions within the it infrastructure, software applications, business analytics and information security arenas.
- If you are interested in this position, send your resume to firstname.lastname@example.org