Manages contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance.
Manages the safety team on their respective programs. Ensures team has sufficient resources and provides direction on assigned projects and tasks.
Works with other managers and senior management, and develops consistent internal processes and ensures compliance with established processes.
Provides plans and accurate forecasts for all projects and ensures timely progress by monitoring project metrics. Proactively liaises with the Project Manager (as appropriate) and clients and ensures optimal performance and utilization of the safety project team.
Works on more complex global projects.
Manages multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements.
Maintains good communications with other functional groups concerning program and company issues. Collaborates with other employees in problem solving and systems improvement.
Reviews regulatory / pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
Maintains a basic medical understanding of the applicable therapeutic areas and disease states. May participate in on-call duties for specific projects and ensures 24-hr coverage for intake of cases from investigative sites.
Serves as a resource and mentor to other departmental managers. Leads departmental initiatives.
Prepares and presents proposals.
Manages a staff of experienced professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
Education and Experience :
Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
2+ years of management responsibility
preferably should be experienced in PVG clinical trial projects
In some cases, an equivalency, consisting of a combination of appropriate education, training, and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities :
Working knowledge of the global regulatory requirements and the importance of and compliance with procedural documents
Strong knowledge of relevant therapeutic areas as required for processing AEs
General knowledge of pathophysiology and the disease process
Solid project management skills, including financial management
Ability to manage and prioritize a variety of tasks
Proficient in Microsoft Office products and safety databases
Good command of English and ability to translate information into local language where required
Excellent oral and written communication skills
Strong attention to detail and accuracy
Strong critical thinking, problem solving and decision making skills