Patient Safety Risk & Signal Management Product Lead
AstraZeneca
Expertise in pharmacovigilance processes
Knowledge of ngsms and orbit platforms
Understanding of ich e2b/e2c guidelines
This role serves as a strategic leader shaping AstraZeneca's global Patient Safety technology capabilities focused on signal detection and risk management planning
Job Summary
This role serves as a strategic leader shaping AstraZeneca's global Patient Safety technology capabilities focused on signal detection and risk management planning.
The successful candidate will drive modernization initiatives leveraging automation and AI to streamline safety workflows while ensuring alignment with evolving global regulations.
AstraZeneca fosters an inclusive culture where employees are empowered to push the boundaries of science and unleash their entrepreneurial spirit to make a difference in medicine.
Matching Summary
This role serves as a strategic leader shaping AstraZeneca's global Patient Safety technology capabilities focused on signal detection and risk management planning.
Skills & Requirements
Must-have
Expertise in pharmacovigilance processes
Knowledge of NGSMS and ORBIT platforms
Understanding of ICH E2B/E2C guidelines
Experience with GxP compliance requirements
Leadership of IT product delivery teams
Nice-to-have
AI/ML-enabled analytics capabilities
Cloud-native architecture experience
Regulatory inspection support background
Modern SaaS platform management skills
Familiarity with MedDRA coding standards
Key Requirements
BSc or MSc in IT, Life Sciences, or related field
Certifications in Pharmacovigilance or Product Management preferred
Extensive experience with NGSMS and ORBIT technologies