Manager, Safety & PV - BUL - Hybrid

Manager, Safety & PV - BUL - Hybrid

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization.
· Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives.
· Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with senior safety management.
· Manages projects where Safety and Pharmacovigilance are the primary services.
o Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed.
o Works with Finance to ensure appropriate customer invoicing, where required.
o Approves project time cards and invoicing.
o Provides sponsors with scheduled project updates and reports.
o Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues.
Participates in the management of the Safety and Pharmacovigilance department with the following actions:
o Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs)
o Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan.
o Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions.
o Works with Business Development to actively solicit new business, as needed.
o Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings.
· Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately reflects the scope of work for Safety and pharmacovigilance. Participates in bid defense meetings.
Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form. Approves budget projections for the project.
· Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process.
· Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentor Safety team members
· Managing resourcing's needs/issues and escalating to senior management as necessary.
· Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions.
· Performs other work related duties as assigned.
· Minimal travel may be required.

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.

Summary

Typically involved in cross-domain topics, can be called upon to address complex data stewardship, data profiling or quality assurance topics. Service Management (with IT teams, with data governance, across data management workstreams) Performance management (Reporting, Managing KPI compliance, Invoicing). Manages Safety team members responsible for all Safety services while adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, Good Pharmacovigilance Practices (GVP) and study procedures. Participates in process development, budget reviews, and project management. Ensures consistency and communication between the Safety team members and management.