|Category||Safety & Pharmaco|
JOB SUMMARY 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.
• 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.
• BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience
• Progressive responsibility with demonstrated leadership skills and project management
• Clinical Research Organization (CRO) experience with therapeutic specialties preferred
• Working knowledge of financial budgets and various financial analysis tools preferred
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet
• Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills
• Ability to establish effective relationships with clients as well as team members
• Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment
• Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment
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.
FLSA status : Exempt
Years of experience required : Six (6) years of Safety and Pharmacovigilance experience
Physical Requirements : Position requires: ability to occasionally move about inside the office to access filing cabinets, office equipment, etc. and to move between office locations; ability to maintain a stationary position for prolonged periods of time; ability to occasionally manipulate (e.g., lift, carry, move) office items and packages of light to medium weights of 10-35 pounds; ability to constantly operate a computer and other office productivity equipment (e.g., scanner, phone, printer, copier); ability to perceive and assess written materials for prolonged periods of time; and ability to frequently communicate with colleagues on the phone, by email, and in-person.
Work Environment : This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The noise level in the work environment is low. This is a largely sedentary role.