Signal Detection/Drug Safety Associate II
Saviance is a US Healthcare IT Service provider focusing on Patient Engagement with Innovative Products and Solutions like Patient Intake Tablet, iHealthConnect Wellness Portal, Mobile Applications, Actionable Analytics and ICD-10 Testing Services. Incorporated in 1999 in New Jersey, Saviance offers services & solutions that enable enterprises to achieve critical objectives.
Saviance is a Gold Category Corporate Member with Healthcare Information Management Systems Society (HIMSS), member of mHealth Alliance and Corporate member of NJ-HITEC. We are awarded by INC. 5000 as one of the fastest growing privately held companies in North America.
Job Title: Signal Detection/Drug Safety Associate II
Duties:
Primary 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 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.
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:
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