Offer summary

Qualifications:

Bachelor’s degree in a medical or scientific related field., Minimum 9 years of professional industry experience in clinical research, with 5 years in Safety of Clinical Trial operations within CRO., Competent understanding of worldwide regulations relevant to the safety of Medtech & Pharmaceutical industry., Excellent interpersonal, analytical, managerial, and organizational skills..

Key responsabilities:

Oversee safety management activities including identification, triage, and analysis of safety signals.

Define and maintain safety profiles of high-risk products and drive patient risk management.

Provide oversight to ensure compliance in pre and post market clinical trials for medical devices and applicable IVD products.

Lead and contribute to effective safety strategies and develop solutions for continuous process improvements.

Job description

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.

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