Collaborate with PSPV colleagues to propose new projects, take ownership of business case formation, process assessment, and requirement articulation.
Lead and own the execution of projects or workstreams, defining scope, goals, and objectives, and ensuring successful completion of business-related tasks.
Facilitate in-depth solutioning conversations and analyze business processes to model and guide future improvements.
Act as the Product Owner or Business System Owner for PV systems, overseeing their validation, configuration, maintenance, evolution, and establishing appropriate support systems.
Support audits and inspections for PV systems in scope
Lead the implementation and maintenance of system configuration changes, ensure quality management, and resolve any discrepancies, while coaching, training, and mentoring new Experts or Managers in System Management.
What Youll Bring To the Role:
Degree in life science or computing subject
Fluent in spoken and written English. Understanding of another major European language (French, German, Spanish) preferred
Minimum of 7 years of experience in drug development, with at least 5 years in safety data management, and expertise in Pharmacovigilance systems and databases
Proficient in working with ORACLE databases and highly competent with SQL.
Comprehensive understanding of regulatory requirements for pharmacovigilance and extensive knowledge of drug safety business processes
Strong communication, collaboration, mentoring, and coaching skills, with a demonstrated ability to lead and deliver initiatives while aligning IT solutions with business needs