Director, Business and Process Optimization – Pharmacovigilance

Job not on LinkedIn

🔥 18 hours ago

🇭🇷 Croatia – Remote

⏰ Full Time

🔴 Lead

👔 Director

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Logo of ERGOMED

ERGOMED

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Provide strategic leadership for department operations and resourcing • Develop and authorize strategic business plans with senior leadership • Oversee cross-functional activities, projects and initiatives • Deliver strategic insights, analyses and recommendations for continuous process improvement • Assess compliance with cross-functional processes, systems, applications, training and communications • Lead large, complex, cross-functional process improvement initiatives • Collaborate with stakeholders, peers and leaders on strategy, execution and communications planning • Provide administrative oversight for staffing, budgeting, scheduling and long-term planning • Manage and provide strategic direction to a team • Oversee recruitment, induction, talent development and staff retention • Provide coaching, feedback, performance appraisals, development plans and career coaching • Develop and implement business plans and forecasting • Drive process and systems optimization activities • Oversee or respond to client and internal process audits and CAPAs • Cultivate a continuous improvement environment • Oversee M&A integration activities as an internal transformation consultant

🎯 Requirements

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance • Extensive pharmacovigilance experience • Experience of process improvement, safety applications and systems • 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 in clinical and post-marketing PV • Excellent project management skills • Superior attention to detail, investigative and analytical skills • Outstanding interpersonal, negotiation and problem-solving skills • Superior computer skills, including understanding of clinical management and pharmacovigilance technology and systems • Expert understanding of clinical trial practices, processes and requirements, including regulatory guidelines and directives • Superior oral and written communication skills, including ability to communicate in English orally and in writing • Ability to direct and promote teamwork in multidisciplinary and/or multicultural teams • Ability to drive innovation in process improvements • Outstanding organizational, judgment, analytical, decision-making and interpersonal skills • Certification in process improvement methodologies such as Lean Six Sigma is a plus

🏖️ Benefits

• Flexible remote work options • Collaborative and supportive work environment • Growth and professional development opportunities • Opportunity to work on global projects with real patient-safety impact • Diverse and inclusive workplace • Coaching, feedback, development plans and career coaching • Talent development and retention support

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