JOB SUMMARY

Manages safety function and associates. Responsible for day-to-day managerial oversight of Safety and Pharmacovigilance teams responsible for Safety services, 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. Responsible for client/company relationships, providing input to bid defenses, capabilities presentations, and directing large clinical trials or Pharmacovigilance programs, as directed.

JOB RESPONSIBILITIES

· Serves as interface between Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance.

· Line management responsibilities for Safety and Pharmacovigilance associates and managers. Approves courses of action on associate motivation, training, interviewing and selection, terminations, professional development, performance appraisals, and employee counseling.

· Provides operational oversight of functional teams and projects.

· 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.

· Oversees 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 and acts as a point of escalation for sponsors.

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.

· Oversees the management of the Safety and Pharmacovigilance department with the following actions:

o Participates 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 and technology.

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 proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance. Works actively in proposal development, prepares and participates in bid defenses as needed.

· 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

· Oversees resourcing needs/issues for Safety services and escalating to senior management as necessary.

· Interact with clients and internal staff to provide advice and guidance on safety review issues; provide training and consultation to clients.

· Maintains understanding and ensures compliance of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, GVP modules and the drug development process.

· 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.

· Moderate travel may be required.

QUALIFICATION REQUIREMENTS

· 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.

This job excludes Colorado applicants.

Disclaimer:

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.

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