Provides management of individual case safety reports (SAEs, ADRs, AEs of special interest and other types), reconciliation of SAEs, coding and data retrievals from the safety database. Supports the generation of aggregated safety reports, and Data Monitoring Committees (DMC) reviews.
In addition to the above:
Serves as Lead Drug Safety Associate and coordinates large or global teams of drug safety associates and safety data coordinators on project level, serves as the drug safety point of contact for study teams on project level
Effectively coaches and mentors less experienced drug safety associates
Assumes line management responsibility for smaller teams of drug safety associates
Provides technical and process oversight with respect to safety services for larger full service projects or smaller safety stand-alone projects
Ensures quality and consistency across multiple projects for one client.
Completes first-line review of drafted Safety and Medical Management plans
Supports the SRM management team in the development of training courses as well as SOPs and associated documents
Contributes to business development efforts in Drug Safety for the local business unit including presenting safety services at bid defense meetings.
Participates in the Safety and Risk Management Regulatory Intelligence activities, to retrieve and maintain a global repository of regulatory safety reporting requirements
4-6 years experience of related experience
Demonstrated ability to provide leadership for teams of drug safety associates, including the planning, supervision, and implementation of processes on a project level.
Undergraduate degree or its international equivalent, preferably in life science and/or healthcare professional.
Advanced knowledge in Pharmacovigilance and the regulatory environment governing safety and risk management activities. Experience in leading smaller functional project teams.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.