- You will be responsible for ensuring timely completion of all deliverables by the cross-functional BRM team. To achieve this goal, you will write BRM project plans and work with the Risk Management Leader to schedule meetings, establish timelines, assign tasks, track issues and assure completion of action items. Developing procedures that address the management of safety information to ensure proactive surveillance of assigned NV&D products.
- The BR Physician is responsible for planning and running case review meetings and signaling meetings for all assigned products. Forge effective working relationships with medical leaders in Clinical Development and Medical Affairs, as well as their counterparts at partner companies.
- Overall responsibility for safety and benefit-risk management of assigned products and formulation of responses to regulatory inquiries on product safety issues.
- Work with the Medical Monitor in the review and assessment analytical plans to evaluate safety issues and leverage necessary resources to respond to safety related issues and inquiries. Assess impact of detected safety signals and develop a signal strengthening action plan.
- Owns and directly oversees the content and management of medical safety documents (periodic reports; annual reports; periodic safety updates; issue work- ups; PV Plans; RM plans; RiskMaps; BR Assessments; Expert Reports; responses to Regulatory Agency inquiries regarding product safety), other than expedited Individual Case Safety Reports.
- Work with the Document Management Specialist to ensure that the final version of all medical safety reports that he/she is accountable for are electronically archived and systematically updated (periodic reports; annual reports; periodic safety updates; issue work-ups; PV Plans; RM plans; RiskMaps; BR Assessments; responses to Regulatory Agency inquiries regarding product safety), other than expedited Individual case Safety Reports, submitted to the Regulatory Agencies.
- Assists with Regulatory Agencies inspections within Pharmacovigilance and ensures timely submission of aggregate reports.
- The BRM Physician will support communication of potential safety issues, as well as BR activities and accomplishments to the Senior Management. Supports the PV Operations Leader with staff allocation and forecasting BR resource needs.
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