Director, Principal Patient Safety Scientist - Biopharma
AstraZeneca
Barcelona, Spain
**
Pharmacovigilance strategy leadership
Global risk management plan preparation
Periodic regulatory document management
**
AstraZeneca is seeking a Director, Principal Patient Safety Scientist to oversee pharmacovigilance and risk management for complex biopharmaceutical products in Barcelona, Spain. The role requires significant expertise in patient safety, regulatory documents, and leadership in cross-functional teams.
**
Job Summary
The role provides strategic oversight of safety documents and deliverables for complex products in various development stages.
The incumbent leads the safety strategy for periodic regulatory reports such as PBRERs, PSURs, and DSURs while ensuring compliance with agreed timelines.
This position requires leading cross-functional initiatives to resolve complex safety issues and mediate agreements across the organization.
Matching Summary
Match Score: 75
**
AstraZeneca is seeking a Director, Principal Patient Safety Scientist to oversee pharmacovigilance and risk management for complex biopharmaceutical products in Barcelona, Spain. The role requires significant expertise in patient safety, regulatory documents, and leadership in cross-functional teams.
**
Skills & Requirements
Must-have
Pharmacovigilance strategy leadership
Global Risk Management Plan preparation
Periodic regulatory document management
Cross-functional safety issue resolution
Third-party contract negotiation expertise
Nice-to-have
Advanced epidemiology knowledge
Due diligence participation experience
Mentorship of new GSPs and scientists
Passion for customer-centric approach
Strategic thinking and decisive action
Key Requirements
MD/MSc/PhD in scientific discipline preferred
Life sciences/pharmacy/nursing degree required
Fluent written and verbal English proficiency
Advanced Patient Safety and Clinical Drug Development experience