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Global Pharmacovigilance Senior Manager
1 week ago
Responsibilities Implement and provide input into all PSAM team goals and strategies Lead execution of cross-functional strategic initiatives that ensure external relationships are consistent with regulations and organizational needs and objectives Develop and maintain safety agreements with business partners that are aligned with functional capabilities and requirements, and organizational strategies and objectives Lead development and execution of international initiatives for lifecycle management of external relationships, including ensuring alignment of roles and responsibilities at the international level Assess and evaluate performance metrics associated with the implementation and management of external relationships and identify appropriate measures for enhancing performance Consolidating recommendations and leading the recommendation and design for the improvement of processes that support the execution and management of external business relationships Execute the vision and strategies for developing, implementing, and managing external relationships within GPS Define and implement strategies that govern the development, implementation, monitoring, and lifecycle management of external relationships within GPS Advise senior management on key aspects of GPS development, execution, and management of external relationships Develops inspection readiness plans including the identification and risk mitigation of gaps within the quality management system Supports internal and external PV audits including devising and implementing action plans to address inspection findings Provide a pro-active approach to initiatives within the pharmacovigilance /drug safety department and in cross-functional efforts Qualifications Masters degree & 4 years of directly related experience OR Bachelors degree & 6 years of directly related experience Microsoft Office applications (Word, Excel, PowerPoint) Specialized drafting/contract development skills Ability to research, interpret, and apply laws and regulations Strong analytical and negotiating skills Strong ability to identify and resolve complex problems Strong attention to detail Strong ability to lead and work in teams Solid understanding of success in a matrixed environment/ability to work cross-functionally Excellent written and verbal communication skills Skills: Negotiating Agreements Pharmacovigilance People Management Benefits: Work From Home
