As a Principal Safety Specialist, you will oversee all aspects of pharmacovigilance services for multifaceted projects.
- Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
- Participates in/lead departmental initiatives; Serves as a subject matter expert in designated area.
- Works independently to oversee day-to-day PVG activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
- Functions in a lead role. Exercises independent judgment to troubleshoot and resolve project issues and to identify areas for improvement.
- Serves as primary point of contact in the absence of the manager. Mentors less experienced staff.
- Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.
- Excellent oral and written communication skills including paraphrasing skills
- Expertise in relevant therapeutic areas as required for processing AEs
- Solid project management skills with the ability to manage multiple projects simultaneously
- Proficient at complex clinical study administration including budget activities and forecasting
- Ability to motivate, mentor and provide guidance to less experience staff
- Advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
- Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately
- Excellent understanding of pathophysiology and the disease process
- Advanced computer skills with the ability to work within multiple databases
- Good command of English and ability to translate information into local language where required
Qualification & Experience:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
- Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
- In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Vacancy Type: Full Time
Job Location: Raleigh, NC, US
Application Deadline: N/A