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:
Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process
Quality controls the reportability assessment of ICSR.
Conducts literature surveillance in the selected database(s) as outlined in the project scope of work and as per established procedures; forwards the information to the Medical Director for review and processes received information in accordance with project specific instructions
Responsible for effective and efficient development of the safety section of the Safety and Medical Management Plan, including development of specific processes to assure consistency within the project.
Supports creation of the SAE/AE reconciliation plan and conducts SAE reconciliation in accordance with this plan and other project specific guidelines
Supports analysis and quality control during the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports).
Supports Director of Risk Management in signal detection and risk management activities.
Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately
Participates in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings
Serves as Lead Drug Safety Associate and coordinates small regional teams of drug safety associates and safety data coordinators on project level (not more than three individuals), serves as the drug safety point of contact for study teams on project level
Reports project status (including monthly metrics) to project/functional management within agreed upon timelines
Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours
Proposes solutions for procedural and technical issues
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.
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