Job Description

Signal Detection/Drug Safety Associate II

Contract

Job Title: Signal Detection/Drug Safety Associate II

Responsibilities

• The contractor resource will be the key contact on the SM Simplification Project work streams.
• Bring industry expertise to support the Simplification Project and will provide strategic feedback to GSS and project team.
• Assist the Signal Management Lead to develop the new signal detection process and changes to the signal tracking tool.
• Assess currently utilized quality documents and develop/modify business processes as needed.
• Develop training materials and provide training.
• Develop and implement a consistent process to produce KPIs.
• Work closely with PM to ensure that timelines are met.
• Coordinate and lead 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 integration of 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/WP/PowerPoint and technical writing skills
• Clinical experience a plus

Education

Education:

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