Manage ‘Client’ or ‘Project’ specific PSS operations associated with products
Provide leadership and management of global or regional projects
Monitor and manage the workflow for assigned projects
Work closely with clinical operations and project management groups
Ensure all PSS activities are performed according to regulatory and contractual requirements
Review of adverse events for completeness, accuracy, appropriateness for expedited reporting
Prepare follow-up correspondence with medical staff
Provide oversight of the management and processing of expedited safety reports (ESRs)
Complete triage, distribution checklist and quality review of all ESRs
Prepare and participate in audits

Non-degree + 6-7 yrs. Safety experience
Associate degree + 5-6 yrs. Safety experience
Associate degree RN + 5-6 yrs. Safety experience
BS/BA + 4-5 yrs. Safety experience
MS/MA + 3-4 yrs. relevant experience or 2-3 yrs. Safety experience
PharmD + 2-3 yrs. relevant experience or 1-2 yrs. Safety experience
Degree preferred in Biological Sciences, Pharmacy, Nursing, Life Sciences, Chemistry
Compliance with client and global regulatory requirements
Good knowledge of pharmacovigilance regulations and guidelines
Good knowledge of Good Clinical Practice (GCP)
Good knowledge of ICH guidelines
Good knowledge of medical and drug terminology
Good keyboard skills, preferably with MS office and Windows

Project Manager – Patient Safety

Key skills