Global Safety Senior Manager

Desired Skills: MS Office Suite,Pharmacovigilance,Regulatory Affairs,Safety,Global Safety,Regulatory Affairs

The Role

PE Global are recruiting for a Global Safety Sr Mgr for our biopharmaceutical client based in Dun Laoghaire, Dublin. This is a 12-month contract, mainly remote role.

Job Responsibilities

• 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

Educations & Experience

• Master’s degree & 4 years of directly related experience
  OR
  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

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV aisling.oleary@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****