Work Schedule
Environmental Conditions
Job Description
Join us as Manager PVG – And lead the efforts in managing and optimizing drug safety operations to ensure the highest standards of patient safety and regulatory compliance in clinical trials.
What You’ll Do:
- Manage multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements.
- Maintain good communications with other functional groups concerning program and company issues. Collaborating with other employees in problem solving and systems improvement.
- Review regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
- Maintain a basic medical understanding of applicable therapeutic areas and disease states. May participate in on-call duties for specific projects and ensure 24-hr coverage for intake of cases from investigative sites.
- Provide plans and accurate forecasts for all projects.
- Serve as a resource for other departmental managers and lead departmental initiatives.
- Prepare and present proposals.
- Manage 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. Approve courses of action on salary administration, hiring, corrective action, and terminations. Review and approve time records, expense reports, requests for leave, and overtime.
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification to include 3+ years of safety experience
- Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- 1+ year of leadership responsibility
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:
- Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.
- Working knowledge of the global regulatory requirements and the importance of and compliance with procedural documents