Description

Sponsor Dedicated Associate Director, Safety & Risk Management - Home Based EMEA 

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.  We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job responsibilities 

Provides 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.

• Collaborates in the development of innovative methods to develop the next generation for Risk Management Sponsor team.

• Partners with the Risk Assessment Management Head to instate and maintain processes and changes.

• Champions for managing and building the risk management knowledge for the organization.

• Provides expertise regarding RMP requirements and implementation for pre-marketed and post-marketed drug products

• Recommends appropriate risk mitigation options for drug related safety issues, taking into account the benefit-risk profile of the drug, and approaches used for other products internal and external to the Sponsor

• Reviews RMP assessment reports to determine if modifications are required

Principal Tasks

In collaboration with Risk Assessment management Head, develops/evolves/implements best practices in risk management planning, including risk communication, risk minimization and in benefit/risk assessment methodologies.

Manager Level

• supports with 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

as the key interface between RAM and the BU in matters related to oversight of implementation and tracking of commitments included within the RMP and provide periodic updates regarding the status of implementation to the RMC

• Leads Product risk management 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.

Senior Manager level

In addition to the responsibilities listed above a Manager RMPL will be required to engage in the following activities and demonstrate the above and following qualities in a leadership capacity:

• Supports with 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 the Sponsor portfolio

• 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

• With oversight, participates in audits and inspections; preparing and coordinating responses; participates in inspection readiness.

Director Level

In addition to the responsibilities listed above a Director, will be required to engage in the following activities and demonstrate the above and following qualities in a leadership capacity:

• Acts as a SME or BPO for a Safety SOP.

• Manages special projects and assists with communications.

• Provides guidance and coaching to less experienced RMPLs, participates in initial training of newly hired RMPLs, acts as first point of contact to assist other RMPLs in issue resolution.

• 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

Qualifications

What we’re looking for
Technical Skills

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

• 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.

• Skills in matrix partnerships to affect inclusive and collaborative working relationships with worldwide colleagues, including engaging Group Heads, Epidemiology Leads and other colleagues supplying sources of safety information. Actively engage global Regulatory, Clinical, Nonclincial, Medical, and relavent individuals from in-country teams as needed.

Qualifications

• B.S., M.S. in health science

• Advanced degree preferred (Pharm.D, or Ph.D, or equivalents)

• Senior Manager level - Minimum 5 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance but with a clear focus on drug safety risk management

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

• Knowledge of global safety regulations and guidelines, or equivalent,

• Demonstrated experience in global drug safety risk management planning activities and generating RMPs

• Demonstrated strength in analytical skills and attention to detail.

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

• Demonstrated organizational/project management skills.

• Familiarity with management of performance metrics

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

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

 

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.