Designation – Signal Detection and Management
1. Assist the Signal Management Lead to develop the new signal detection process and changes to the signal tracking tool.
2. Assess currently utilized quality documents and develop/modify business processes as needed.
3. Develop training materials and provide training.
4. Develop and implement a consistent process to produce KPIs
5. Work closely with PM to ensure that timelines are met.
6. Coordinate and lead SMC meetings
1. Experienced in signal detection tools and processes
2. Skilled in implementing new business processes and technology solutions for signal detection in clinical development
3. Experienced in LEAN methodology
4. Working knowledge of regulations related to signal detection (GVP Module IX).
5. Proven expertise working with FAERS and WHO-Vigibase data
6. Ability to review complex information to develop business related strategies for integration of clinical development data and real-world data in the signaling process
7. At least 2-3 years of pharmacovigilance experience, especially in signal detection and management.
8. Strong consulting experience
9. Excellent Excel/WP/PowerPoint and technical writing skills
10. Clinical experience a plus
This is a great opportunity for experienced Safety Writers working within the pharmaceutical, biotech and Contract Research Organization (CRO) sector,...Aplikuj na tą ofertę
The Role: Moderna is seeking an Associate of ICSR Quality, Pharmacovigilance Operations, to provide key operational support throughout the lifecycle...Aplikuj na tą ofertę