Signal Detection/Drug Safety Associate II at Integrated Resources Inc.

Responsibilities

• Serve as the key contact on the SM Simplification Project work streams.
• Bring industry expertise to support the Simplification Project and provide strategic feedback to GSS and the project team.
• Assist the Signal Management Lead in developing the new signal detection process and changes to the signal tracking tool.
• Assess currently utilized quality documents and develop or modify business processes as needed.
• Develop training materials and provide training.
• Develop and implement a consistent process to produce KPIs.
• Work closely with the Project Manager to ensure timelines are met.
• Coordinate and lead Signal Management Committee (SMC) meetings.

Qualifications

• Experienced in signal detection tools and processes.
• Skilled in implementing new business processes and technology solutions for signal detection in clinical development.
• Experienced in LEAN methodology.
• Working knowledge of regulations related to signal detection (GVP Module IX).
• Proven expertise working with FAERS and WHO-Vigibase data.
• Ability to review complex information to develop business-related strategies for integrating clinical development data and real-world data in the signaling process.
• At least 5+ years of pharmacovigilance experience, especially in signal detection and management.
• Strong consulting experience.
• Excellent Excel, Word, PowerPoint, and technical writing skills.
• Clinical experience a plus.

This is a contract position.