Signal Detection/Drug Safety Associate II

Integrated Resources Inc.; Bridgewater (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A healthcare consulting firm located in Bridgewater, Massachusetts, is seeking an experienced Signal Detection/Drug Safety Associate II. In this role, you will act as the key contact for the SM Simplification Project, providing expertise in signal detection tools and processes. The ideal candidate has over 5 years of pharmacovigilance experience, strong consulting skills, and proficiency in regulatory frameworks. This contract position offers an opportunity to lead initiatives aimed at enhancing signal management practices.

Qualifications

• 5+ years of pharmacovigilance experience, especially in signal detection and management.
• Experience in developing training materials and conducting training sessions.
• Ability to coordinate and lead meetings effectively.

Responsibilities

• Key contact on the SM Simplification Project work streams.
• Provide strategic feedback to project teams.
• Assist in developing new signal detection processes.
• Develop and implement KPIs.

Skills

Signal detection tools and processes

Implementing new business processes

LEAN methodology

Regulations related to signal detection

Working with FAERS and WHO-Vigibase data

Reviewing complex information

Consulting experience

Excel/WP/PowerPoint skills

Education

Degree in a relevant field

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: