Signal Management Expert

Main Responsibilities:
- Collaborates with stakeholders across PSPV to ensure a compliant and efficient signal management process accounting for interdependencies with other PV and cross-functional activities
- Manages the process and systems for routine signal detection and tracking of signal assessment
- Monitors external environment (regulations, literature, professional societies) for insights and innovation of the signal management system
- Partners with digital teams to administer, improve, and implement digital systems used for signal detection and management
- Understands and evaluates signal detection data sources, methods, and tools to enhance safety surveillance processes and systems
- Provides training and ongoing support to roles executing signal detection and signal management (e.g., GSOs, PVS, Therapeutic Area Heads, Country Safety Heads)
- Coordinates and oversees outsourced PV activities (e.g., maintenance of signal detection schedules; business administration of systems)

Experience/Qualifications:
- Minimum 2 years of experience in a pharmaceutical, biotech, or other regulated environment
- Evaluation, interpretation, and communication of scientific data
- Experience identifying, evaluating, and implementing process improvement initiatives including CAPAs
- Working knowledge of pharmacovigilance and drug safety practices including US and EU regulatory requirements

Technical/Other Skills:
- Working knowledge of common data processing software and database systems
- Ability to map, analyze, and measure processes
- Strategic thinker; able to assess impact of interconnected activities, projects, and systems
- Proficiency with MS applications
- Team player in cross-functional environments; self-motivated and able to prioritize by impact; ability to influence across stakeholders

Education:
- Bachelor’s degree in a healthcare, life sciences, or STEM discipline
- Preferred: Doctor of Pharmacy, Master of Science, or PhD
- English (business proficiency)