Director, Business and Process Optimization (Pharmacovigilance)

PrimeVigilance Ltd.; Raleigh (NC); On-site; USD 180,000 - 250,000; Full time

Job summary

PrimeVigilance Ltd. is seeking a Director of Business and Process Optimization (Pharmacovigilance) to drive strategic direction and oversee operations for the department.

You will lead cross-functional teams, shape strategic plans, and ensure continuous improvement across processes and systems. The role demands extensive PV experience, strong leadership, and a track record of implementing process improvements in a service-provider environment.

Qualifications

• Life science degree or healthcare qualification and PV experience.
• Experience leading PV process improvement initiatives and cross-functional projects.
• Proven leadership in PV from a service provider environment.
• Strong project management and organizational skills.

Responsibilities

• Provide strategic direction to the business operation and cross-functional teams.
• Lead development and execution of strategic business plans with senior leadership.
• Oversee a portfolio of cross-functional initiatives delivering insights and driving improvement.
• Act as business lead for large, cross-functional process optimization projects.
• Manage staffing, budgeting, and long-term planning for the department.

Skills

PV leadership

Process improvement

Project management

Stakeholder management

English fluency

Education

Life science degree

Tools

Pharmacovigilance systems

Job description

Director, Business and Process Optimization (Pharmacovigilance)

• Full-time
• Department: Business and Process Optimization

Medicine moves forward here. So will you.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

The Director, Business and Process Optimization serves as a key member of the leadershipteam, providing strategic leadership in the direction and execution of the operations and resourcingfor the department in a complex cross-functional environment to develop and execute strategies thatensure continuous process improvement and optimize organizational performance, processes, andassociated 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 drivestrategy, execution and communications planning to achieve continuous processimprovement 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, schedulingand long term planning. Provides strategic direction to staff through line management of ateam. Accountable for effective recruitment, induction, talent development and retention ofstaff. Provides ongoing coaching and feedback including formal performance appraisals,development plans and career coaching.
• Develops and implements business plans, forecasting and proactively supports and drivesprocess 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
• Outstanding organizational, judgment, analytical, decision making and interpersonal skills to manage complex projects inparallel and manage rapidly changing priorities

REQUIREMENTS

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• Extensive pharmacovigilance experiencewith experience of process improvement, safety applicationsand systems including demonstratedlinemanagement experience
• Extensive leadership experience in PV from a service providerenvironment
• Experience optimizing processes and managing through toimplementation
• 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 asLean Six Sigma is a plus
• Superior attention to detail, investigative and analytical skills
• Outstanding interpersonal, negotiation and problem solvingskills
• Superior computer skills, to include an effectiveunderstanding of clinical management and pharmacovigilancetechnology andsystems
• Expert understanding of the practices, processes andrequirements of clinical trials, to include regulatory guidelinesand directives
• Superior oral and written communication skills including theability 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 relatedto process improvements
• Outstanding organizational, judgment, analytical, decision making and interpersonal skills to manage complex projects inparallel and manage rapidly changing priorities

ABOUT ERGOMED GROUP

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.

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