Job Description: As a Principal Safety Specialist, you will oversee all aspects of pharmacovigilance services for multifaceted projects. Job Responsibilities: 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. Job Requirements: 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. Job Details: Company: PPD Vacancy Type: Full Time Job Location: Raleigh, NC, US Application Deadline: N/A Apply Here careersvite.com
Careers Vite – Latest Jobs 2025