Senior Director, Global Safety Management

Summary

Join RQM+, a leading MedTech service provider, as a Sr. Director, Global Safety Management. You will provide safety and department leadership to clinical development programs, overseeing safety management activities including signal identification and analysis. Responsibilities include defining safety profiles, driving patient risk management, and ensuring compliance with global safety regulations. This role requires a Bachelor's degree, extensive experience in clinical research and safety, and strong leadership and communication skills. RQM+ offers a rewarding work environment with an industry-leading compensation package and a focus on work-life balance.

Requirements

• Bachelor’s degree in medical or scientific related field
• Minimum 9 years of professional industry experience in clinical research (medical devices and pharmaceutical industry) with 5 years in Safety of Clinical Trial operations within CRO
• Competent understanding of worldwide regulations relevant to the safety of Medtech & Pharmaceutical industry in development and in post market setting
• Working knowledge of all applicable safety and reporting regulations for high-risk products, globally
• Up to 20% travel may be required including international travel
• Strategic Thinking– Demonstrated ability to analyze, frame, and communicate complex issues, including writing and presentation proficiency
• The ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems
• Excellent interpersonal, analytical, managerial, and organizational skills
• Excellent verbal and written communication
• The ability to work independently, and the ability to motivate, mentor, influence and collaborate with others in a complex global organizational matrix is essential
• Working knowledge of Word, Excel, and PowerPoint required
• Ability to work in an intense, fast-paced, multinational work environment
• Ability to effectively communicate with employees, colleagues, and global teams
• Positive motivator and leader
• Ability to collaborate with internal and external leaders to ensure consistency of actions and decision-making with overall functional strategies
• Organizational Development – Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies

Responsibilities

• Define and or maintain safety profiles of high-risk products
• Drive patient risk management
• Overall Management and oversight of the Global Safety Quality systems
• Implements opportunities identified for consistency and standardization in Safety
• Represents Global Safety at internal strategic and/or advisory/governance committees
• Partners with internal stakeholders within Global Safety as well as other RQM+ functions and affiliates to deliver integrated safety and risk management support to the RBM+ business Lead and contribute to effective and efficient proactive safety strategies for the assigned processes and delivery of operational safety aspects
• The provision of key expertise and guidance to concerned Global Patient Safety functions and other functions within the company, as well as vendors for safety operational tasks
• Developing, optimizing, implementing, and documenting appropriate processes to ensure safety reporting compliance in the area of responsibility
• Define and report out metrics to Senior Management through documented triggers, and furthermore implement, monitor, and communicate performance and develop solutions for continuous process improvements
• Provide oversight to ensure sponsor’s and sites required compliance involved in pre and post market clinical trials for medical devices, applicable IVD products and combination products
• Is responsible for people management activities; coaches, counsels and develops a proactive-solution oriented approach to safety signal detection, evaluation and resolution
• Interacts with Business development
• Involved in indication-specific Safety strategy planning and implementation across the assigned therapeutic areas
• Reviews RFPs, and makes recommendations for bidding when Global Safety is involved

Preferred Qualifications

Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Benefits

• Industry leading compensation package
• Deeply engrained focus on work life balance