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.
·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
·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
oReviews study budgets and
expenses; ensures all study related contractual and budgeting issues are upheld
oWorks with Finance to ensure
appropriate customer invoicing, where required.
oApproves project time cards
oProvides sponsors with
scheduled project updates and reports and acts as a point of escalation for
oCoordinate 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:
oParticipates in the
development, review, and approval of departmental Standard Operating Procedures
oReviews, provides input, and
ensures the execution of the Safety Management Plan/Safety Reporting Plan.
oEvaluates processes for
potential improvement in efficiency and effectiveness and recommends changes.
Participates in process development and improvement of departmental functions
oWorks with Business
Development to actively solicit new business, as needed.
oRepresents Safety and
Pharmacovigilance or ensure Safety representation at project team meetings and
·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.
·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.
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.
Years of experience required:Eight (8) years of Safety and Pharmacovigilance experience including three (3) years of line management 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.
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