PV Aggregate Reports Scientist
Core
Lead and conduct authoring and project management of aggregate safety reports (PSURs, DSURs, PADERs) and serve as a subject matter expert on global safety requirements.
Role type
Senior IC PV Aggregate Reports Scientist (Management level)
Builds
Global aggregate safety reports and compliant processes for assigned product groups
Domain
Life Sciences / Pharmacovigilance
Required skills
Pharmacovigilance experience, Aggregate safety reports writing, Safety signal management, Clinical judgment, Regulatory legislation review, Data analysis
Preferred skills
Advanced degree (MSc/PhD), Advanced medical concepts knowledge, Demonstrated authoring experience
Technologies
Excel, PowerPoint, Microsoft Word, Business Objects, Safety database systems
Responsibilities
Lead authoring and project management of aggregate safety reports, Conduct worldwide legislation reviews, Assist in authoring responses to regulatory safety questions, Contribute to process improvement initiatives, Interpret and present scientific and medical data, Collaborate with cross-functional teams
Seniority
Senior, Management