Associate Director leading strategic engagements for clients selecting ERP solutions. Advising on ERP strategy and guiding vendor - agnostic decisions for transformational impact.
About the role
- Director overseeing case processing in global pharmacovigilance at CSL Behring. Leading compliance and optimization while managing medical review and case management processes.
Responsibilities
- Oversees all areas of single case processing in the global pharmacovigilance database from all sources
- Ensures that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs
- Responds to specific questions or queries about cases
- Develops standards and processes, with a focus on global compliance and process optimization
- Oversees Medical Evaluators responsible for medical review of ICSRs
Requirements
- Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience
- 5 years of managerial/leadership experience
- Global pharmacovigilance database knowledge is required
- Proficient knowledge of global and local regulatory rules and regulations
- BS/BA, RN, Pharmacist, or similar
Benefits
- Health insurance
- 401(k) matching
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
MS
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