Director, Business and Process Optimization (Pharmacovigilance)

Job Description

The Director, Business and Process Optimization serves as a key member of the leadership team, providing strategic leadership in the direction and execution of the operations and resourcing for the department in a complex cross-functional environment to develop and execute strategies that ensure continuous process improvement and optimize organizational performance, processes, and associated systems, training and communications in order to achieve business goals and objectives.

ROLE AND RESPONSIBILITIES

• Provides management & strategic direction to the business operation/corporate function. 
• Participates with senior leadership in developing and authorizing the implementation of strategic business plans. 
• Oversees a portfolio of cross-functional activities, projects and initiatives delivering strategic insights, analyses and recommendations to drive continuous process improvement and assess compliance with cross-functional processes and associated systems/applications, training and communications. 
• Serves as business lead for large, complex, cross-functional process improvement initiatives. 
• Collaborates, innovates and consults with multiple stakeholders, peers and leaders to drive strategy, execution and communications planning to achieve continuous process improvement and departmental and organizational business imperatives, goals and objectives 
• Oversees initiatives to develop, optimize, improve and assess compliance with cross functional processes and associated systems/applications, training and communications. 
• Provides administrative oversight of the department, including staffing, budgeting, scheduling and long term planning. Provides strategic direction to staff through line management of a team. Accountable for effective recruitment, induction, talent development and retention of staff. Provides ongoing coaching and feedback including formal performance appraisals, development plans and career coaching. 
• Develops and implements business plans, forecasting and proactively supports and drives process and systems optimization activities. 
• May provide oversight and/or responses for client or internal process audits on processes, systems, or procedures and/or CAPAs.
• Cultivates an environment of continuous improvement 
• Acts as an internal transformation consultant in overseeing M&A integration activities

Qualifications

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance 
• Extensive pharmacovigilance experience with experience of process improvement, safety applications and systems including demonstrated line management experience
• Extensive leadership experience in PV from a service provider environment 
• Experience optimizing processes and managing through to implementation
• Outstanding leadership and management skills 
• Advanced skill in process development and improvement, especially as it applies to clinical and post-marketing PV 
• Excellent project management skills 
• Certification in process improvement methodologies such as Lean Six Sigma is a plus 
• Superior attention to detail, investigative and analytical skills 
• Outstanding interpersonal, negotiation and problem solving skills 
• Superior computer skills, to include an effective understanding of clinical management and pharmacovigilance technology and systems 
• Expert understanding of the practices, processes and requirements of clinical trials, to include regulatory guidelines and directives 
• Superior oral and written communication skills including the ability to communicate in English, both orally and in writing 
• Capable of directing and promoting teamwork in a multidisciplinary and/or multi-cultural team setting 
• Capable of driving innovation in developing new ideas related to process improvements 
• Outstanding organizational, judgment, analytical, decision making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.  

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. 

• Quality: we hold ourselves to the standard patients deserve. 

• Integrity and trust: we do the right thing, especially when it is hard. 

• Drive and passion: we care about the outcome, because someone is waiting on it. 

• Agility and responsiveness: we move quickly, because patients cannot wait. 

• Belonging: everyone is welcome, and every voice counts. 

• Collaborative partnerships: we go further by going together. 

We look forward to welcoming your application.