Manager – Global Patient Safety – Remote – Dun Laoghaire, Dublin
Office/Project Location: Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Hybrid
Pay: €60 – €70 per hour
Experience: 6+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland’s leading aseptic manufacturing plant.
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
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
Requirements
Bachelor’s 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
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
Competencies
Project management
Conflict management
Directing others
Managing diversity
Listening
Managing and measuring work
Building effective teams
Package
Contract role – Hourly rate €55 – €65 per hour
Minimum 12 month contract with the possibility of an extension.
The role is mostly remote but will require onsite presence when needed.
Contact
Karen McHugh is the consultant managing this position.
If you are a Global Patient Safety Manager interested in roles based in Dublin , you can contact Karen by e-mail at [email protected] Karen or phone 353 1 7979720 for a confidential chat.
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With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Global Patient Safety Managers in Dublin and Ireland.
Due to the large volume of applications, JobContax may not be able to respond to every individual.
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