Drug Safety Contractor
The Drug Safety Contractor will provide quality review of ICSRs, handle surveillance of known or emerging safety issues, and participate in escalation processes, risk evaluation, and analysis of safety data. This position requires the application of broad knowledge of the drug development process to the Drug Safety function and understanding the implications for post-marketing Pharmacovigilance. This individual will have a high degree of cross functional visibility within the clinical study teams as the Product Safety Lead for at least two molecules, with multiple protocols. This contract role can be remote or onsite, and will report to the Director, Clinical Safety & Risk Management.
Responsibilities:
· Apply safety concepts and regulations contained within FDA CFR, ICH, and EU GVP to management of Safety data across the development life cycle
· Analyze aggregate safety data within a clinical program towards tracking and trending of risk assessments and additional mitigation measures
· Identify potential signals and escalate to the medical review function
· Gather and analyze safety data for escalation to the Executive Safety Advisory Committee
· Facilitate correct and timely communication of safety issue
· Contribute to safety sections of the investigational new drug and new drug applications, investigator or regulator communications, Investigator brochure, and other reports (DSUR)
· Participate in the set-up and maintenance of adverse event processes in global clinical trials
· Ensure Quality of the Individual Case Safety Report, including data and a concise, medically relevant narrative
· Ability to oversee a service provider with best practices in a highly regulated environment
· Obtain clinically meaningful information from investigators to provide a robust safety assessment
· Identify areas for improvement and deviations from process. Perform root cause analysis and initiate corrective and preventive action (CAPA) measures when appropriate
· Create and/or contribute to SOP development and “plan” documents within a clinical trial including safety management plan. data management plan, trial master file plan and similar often on a global level
· Develop electronic case report forms, configure the Clinical database for Safety specifications, perform User Acceptance Testing, maintain documentation, and perform reconciliation with the clinical trial data
· Act as a liaison internally and externally (e.g. Clinical Development, Regulatory Affairs, Biometrics, parent company and business partners) to develop programs and processes
· Train and mentor other drug safety staff
· Maintain a current understanding of the Drug Safety and Pharmacovigilance best practices.