Global Safety Manager - Remote

Team Horizon is seeking a Global Safety Sr Manager for a leading Pharmaceutical company based in Dublin.

Design and implement solutions to complex organizational challenges within GPS, manage large-scale changes that impact GPS, maintain the operational processes necessary to manage GPS effectively, and provide strategic support to the leadership of GPS.

The role is mostly remote but will require onsite presence at the Dublin Office when needed.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• 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.

What you need to apply:

• Education & Experience (Basic)  Master’s degree & 4 years of directly related experience OR  Bachelor’s degree & 6 years of directly related experience OR  Associate’s degree & 10 years of directly related experience OR  High school diploma / GED & 12 years of directly related experience.


• 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 skill.


• Strong critical thinking.


• Time management and prioritization/ability to meet deadlines.


• 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.


• Specialized drafting/contract development skills.


• Ability to research, interpret, and apply laws and regulations.


• Strong analytical and negotiating skills.