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.
Applies considerable knowledge of PRA's policies and procedures
Applies knowledge of computerized information systems and standard application software (Windows, MS Office)
Applies knowledge of working in safety databases
Applies knowledge in pharmacovigilance
Develops project specific technical and planning documents in own functional area
Has limited knowledge in managing project budgets
In addition to the above:
2-3 years experience in processing of ICSR and/or
2-3 years experience as a Clinical Data Coordinator, with at least one year experience as Lead Clinical Data Coordinator
Undergraduate degree or its international equivalent, preferably in life science and/or healthcare professional.
Knowledge in pre- and post-marketing Pharmacovigilance. Basic knowledge of regulatory environment governing safety and risk management activities.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.