Global Patient Safety Senior Manager (GPS) - Biopharmaceutical - Dublin

Office/Project Location: Dún Laoghaire, Dublin

Employment Type: 12-Month Contract

Pay: Hourly Rate €60-€65

Experience: 4+ years postgraduate experience

Visa: EU passport or Stamp 4 visa required

Our client is a global biopharmaceutical leader specializing in the development, manufacturing, and commercialization of innovative biological therapies and human therapeutics.

A Global Patient Safety Senior Manager (GPS) is required within Global Pharmacovigilance Safety Agreement Management (PSAM).

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

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

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 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

Project management

Conflict management

Directing others

Managing diversity

Listening

Managing and measuring work

Building effective teams

Package

Hourly rate €60-€65

12-month contract

Remote flexibility

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 karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Global Patient Safetys in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.

taglife