Assist the Signal Management Lead in developing new signal detection processes and changes to the signal tracking tool. Participate in signal detection activities, including setup and reviewing line listings for signal detection reports. Draft complex signal detection reports, perform quality control, evaluate, and categorize potential signals, and propose actions for identified signals. Ensure compliance with relevant procedures and regulatory requirements, provide support for regulatory communication, develop training materials, and implement consistent KPI processes. Collaborate with project management to meet timelines.
Responsibilities
- Signal Management Support: Assist in developing new signal detection processes and modifying the signal tracking tool.
- Signal Detection Activities: Participate in setup and review line listings for signal detection reports.
- Report Drafting: Draft complex signal detection reports, including quality control, and evaluate and categorize potential signals.
- Action Proposals: Propose actions for identified potential signals.
- Regulatory Compliance: Work with other departments to ensure signal management adheres to procedures and regulatory requirements.
- Regulatory Communication Support: Provide support for preparing communications with regulatory authorities.
- Training Development: Develop training materials and provide training.
- KPI Process Implementation: Develop and implement consistent processes to produce KPIs.
- Project Management Collaboration: Work closely with project management to ensure timelines are met.
Skills
- Regulatory Requirements
- Signal Detection
