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:
#J-18808-LjbffrSignal Detection/Drug Safety Associate II in bridgewater at Unknown Company
This position is listed as contract and onsite.