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PV Manager – Safety Science

About the role

• Coordinate contracted safety responsibilities for one or more programs, including staffing, training, procedural compliance and technology oversight
• Manage safety teams on respective programs
• Work with senior management to develop consistent internal processes and ensure compliance
• Liaise with project leads and clients to ensure optimal performance, utilization of the safety project team and high-quality service delivery
• Directly fulfill safety scientist activities on assigned projects
• Oversee a multinational team of safety scientists
• Oversee maintenance of applicable technology platforms
• Manage contractual, procedural and regulatory aspects of local and global projects
• Maintain communications with other functional groups and collaborate on problem solving and systems improvement
• Review regulatory/pharmacovigilance publications and information sources
• Maintain understanding of applicable therapeutic areas and disease states
• Participate in on-call duties for specific projects
• Provide plans and accurate forecasts for assigned projects
• Serve as a resource to departmental managers and lead departmental initiatives
• Prepare and present proposals
• Manage experienced professional staff, including interviewing, selection, professional development, goal setting, performance management, coaching, mentoring, employee counseling and separations
• Approve salary administration, hiring, corrective action and termination actions
• Review and approve time records, expense reports, leave requests and overtime
• Monitor and manage team-member utilization
• Contribute to signal detection, aggregate safety report writing and other product safety science tasks

• 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, which may include serving as a project lead
• An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient
• Working knowledge of global regulatory requirements applicable to pharmacovigilance and compliance with procedural documents
• Excellent attention to detail
• Strong data interpretation and medical-scientific writing skills
• Time management and project management skills
• 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 critical thinking, problem solving and decision-making skills

• Continued career advancement opportunities
• Award-winning training
• Benefits focused on the health and wellbeing of employees