Director, Risk Management - Europe - FSP

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At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP has an exciting opportunity for a Director, Risk Management to join our team in Europe. This role can also be based in any European location and will be a fully remote home-based position.

The successful candidate must have advanced/fluent English language skills, oral and reading/writing.

Job Summary:

The Director, Risk Management will provide strategic expertise to product teams and will drive the execution of Risk Management (RM) activities included within RMP (Risk Management Plans) across business units to embed a culture of innovative and efficient risk management strategies to enhance patient safety.

They will provide expertise regarding RMP requirements and implementation for pre-marketed and post-marketed drug products and recommend appropriate risk mitigation options for drug related safety issues, considering the benefit-risk profile of the drug, and approaches used for other products both internally and externally.

Key Accountabilities:

• Acts as a SME for Safety SOPs.

• Manages special projects and assists with communications. Provides guidance and coaching to less experienced colleagues; participates in initial training of newly hired team members, acts as first point of contact to assist others in issue resolution as necessary.

• Has the foresight and judgement to recommend and then manage external safety KOL consultations, expert working groups, and other external safety forums.

• Implements opportunities identified for consistency and standardization in Safety.

• Identifies and evaluates issues and presents strategies to ensure that timelines are met or accelerated.

• Influences above country and local individuals responsible for Safety, Regulatory, and Medical for appropriate risk management development and implementation.

• With oversight, provide strategic guidance for risk management planning, taking into consideration local regulatory requirements, risk management best practices, and product specific risk profile, and development and implementation of RMP initiatives for products within the sponsor portfolio

• Leads using effective leadership and process management techniques.  Builds appropriate agendas, provides draft and final minutes and drives the actions to completion. Responsible for the storage and tracking of action items from meetings. Ensures appropriate membership attendance for internal and external meetings, including external expert engagement and briefing.

• Manages supplier performance/delivery relative to defined and agreed upon SOW; support managing day-to-day supplier communications.

• Provides regular reporting on all aspects of RMP milestones/performance per specific targets as defined by key performance indicators (KPIs) and/or regulatory commitments through maintenance and presentation of project performance dashboards.

• With oversight, creates/maintains project planning and execution documentation including, but not limited to, project charters, detailed project plans/milestones, progress reports, activity logs and deliverables, i.e. RMP submissions.

• Updates/maintains assigned project related documentation as per defined in risk management processes and file structure on designated system.

• Creates/maintains project planning and execution documentation including, but not limited to, project charters, detailed project plans/milestones, progress reports, activity logs and deliverables, i.e. RMP submissions.

• Provides risk management education to internal and external colleagues.

• Participates in audits and inspections; preparing and coordinating responses; participates in inspection readiness.

Skills and Experience:

• Minimum 10 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance but with a clear focus on drug safety risk management.

• High level analytical skills - Detail oriented, independent, and manage processes to both establish timelines and ensure timelines are met. Excellent organizational skills.

• Strategic Thinking – Demonstrated ability to analyze, frame, and communicate complex issues, including writing and presentation proficiency.

• Clinical, Regulatory and Safety Expertise - Demonstrated knowledge of clinical research processes, safety or regulatory requirements. Knowledge of Risk Management regulations and drug development process.

•  Knowledge of global safety regulations and guidelines, or equivalent. Demonstrated experience in global drug safety risk management planning activities and generating RMPs.

• Technical Expertise – Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line.

• Scientific/Administrative Excellence - Demonstrated ability to scientifically evaluate and document review and analysis of data.

• Organizational Development – Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies.

• Project and Process Management & Meeting Established Deadlines – Demonstrated ability to manage multiple complex projects and cross-functional processes and to meet established deadlines. Experience in budgetary management.

• Computer applications - MS Word, Excel, PowerPoint presentations, etc., as well as department systems.

• Demonstrated strength in analytical skills and attention to detail.

• Demonstrated strength in oral/written communication, negotiation, and interpersonal skills.

• Significant knowledge of matrix-based decision-making is required.

Education:

• B.S., M.S. in health science. Advanced degree preferred (Pharm.D, or Ph.D, or equivalents).

• Project management certification (PMP) and Six Sigma Certification preferred.

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