Global Safety Senior Manager

Global Safety Senior Manager

12 Months

AS34085

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Ideally the person will have experience in globally developing, documenting, and managing partnered relationships within GPS in a way that reflects the organization’s strategic and operational need, along with being an SME in the development of new techniques or plans within area of expertise.

Responsible for:

• Globally developing, documenting, and managing partnered relationships within GPS in a way that reflects the organization’s strategic and operational need
• Identifying opportunities to improve operational efficiencies and identify, avoid, and/or minimize the risks of regulatory and contractual non-compliance and other business loss
• Leveraging business acumen and subject matter expertise in the development of new techniques or plans within area of expertise.
• Developing creative and innovate output based on interpretation and analysis

• 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.

• Master’s degree & 4 years of directly related experience/Bachelor’s degree & 6 years of directly related experience/Associate’s degree & 10 years of directly related experience/High school diploma / GED & 12 years of directly related experience.
• Ability to research, interpret, and apply laws and regulations
• Knowledge of the fields of Regulatory Affairs and Safety
• Knowledge of Regulatory and Safety functional activities
• Knowledge of pharmacovigilance systems
• Knowledge of regulations governing pharmaceutical industry