Senior Director, Global Safety Management

 RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

The Sr. Director, Global Safety Management provides safety and department leadership to clinical development programs for Sponsors at RQM+. This person will oversee and performs safety management activities with identification, triage and analysis of safety signals.

Responsibilities:

• Define and or maintain safety profiles of high-risk products and
• 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

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

Behaviors

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

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! 

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers

Every candidate going through the interview process will participate in a voice and/or video interview.

Exercise caution with unsolicited job offers or requests for sensitive information.

This job operates in a professional office environment in a global organization. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch, or crawl.

We are committed to promoting equality of opportunity for all staff and job applicants. We aim to create a working environment in which all individuals can make best use of their skills, free from discrimination or harassment, and in which all decisions are based on merit.

Our selection for recruitment does not discriminate based on age, disability, gender reassignment, marital or civil partner status, pregnancy or maternity, race, color, nationality, ethnicity, ethnic or national origin, religion or belief, sex or sexual orientation or gender reassignment status (protected characteristics).