Pharmacovigilance Manager
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Job Description
Pharmacovigilance Manager leading clinical-trial drug safety operations at Thermo Fisher Scientific. Managing regulatory compliance, projects, forecasts, and experienced PVG professionals.
Responsibilities:
- Manage and optimize drug safety operations for clinical trials
- Manage contractual, procedural, and regulatory requirements across local and global projects
- Maintain communication with functional groups regarding program and company issues
- Collaborate on problem solving and systems improvement
- Review pharmacovigilance publications and information sources to stay current on regulations, practices, procedures, and proposals
- Maintain basic medical understanding of applicable therapeutic areas and disease states
- Participate in on-call duties and ensure 24-hour case-intake coverage when required
- Provide project plans and accurate forecasts
- Serve as a resource for departmental managers and lead departmental initiatives
- Prepare and present proposals
- Manage experienced professional staff, including hiring, development, performance management, coaching, counseling, and separations
- Approve salary administration, hiring, corrective action, terminations, time records, expense reports, leave requests, and overtime
Requirements:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification, including 3+ years of safety experience
- Previous experience comparable to 5+ years
- 1+ year of leadership responsibility
- Working knowledge of global regulatory requirements and procedural compliance
- Strong knowledge of relevant therapeutic areas for processing adverse events
- General knowledge of pathophysiology and disease processes
- Time management and project management skills
- Proficiency 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
Benefits:
- Collaboration and development opportunities
- Global team environment
- Scientific excellence-focused work environment
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