Global Safety Senior Manager

PE Global (UK); Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

PE Global (UK) is recruiting for a Global Safety Sr Mgr for our biopharmaceutical client based in Dun Laoghaire, Dublin. This role is a 12-month contract with a mainly remote work structure.

The ideal candidate will develop and manage global safety initiatives that reflect organizational needs. You will possess strong analytical skills and experience in regulatory affairs, while also leading cross-functional teams to meet strategic objectives.

Qualifications

• Master’s degree with 4 years experience or Bachelor's degree with 6 years experience.
• Ability to interpret and apply laws and regulations.
• Strong verbal and written communication skills.
• Knowledge of regulations governing the pharmaceutical industry.

Responsibilities

• Develop and manage partnered relationships within GPS.
• Identify opportunities for operational efficiencies.
• Lead execution of cross-functional strategic initiatives.
• Ensure alignment of roles and responsibilities internationally.
• Develop inspection readiness plans for quality management.

Skills

Microsoft Office applications

Analytical skills

Negotiating skills

Problem-solving

Attention to detail

Leadership in teams

Critical thinking

Time management

Education

Master’s degree and 4 years of related experience

Bachelor’s degree and 6 years of related experience

Tools

Pharmacovigilance systems

Regulatory Affairs knowledge

Job description

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 innovative 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 [e-mail].

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