PV Manager, Safety Science

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3 days ago

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Thermo Fisher Scientific

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Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Coordinates contracted safety responsibilities for one or more programs, including staffing, training, procedural compliance and technology oversight • Manages the safety team on respective programs • Works with senior management and develops consistent internal processes and ensures compliance with established processes • Proactively liaises with project leads and clients to ensure optimal performance and utilisation of the safety project team and delivery of a high quality service to our clients • Directly fulfils safety scientist activities on assigned projects • Oversees a multinational team of safety scientists • Oversees maintenance of applicable technology platforms • 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 understanding of applicable therapeutic area and disease states • Prepares and presents proposals • Manages staff of experienced professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counselling, 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 • Proactively monitors and manages utilization of individual team members

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 3+ years of safety experience (including signal detection, aggregate safety report writing or other safety science tasks) • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) • 1+ year of leadership responsibility, which may include serving as a project lead • Working knowledge of the global regulatory requirements applicable to PV and the importance of 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

🏖️ Benefits

• continued career advancement opportunities • award-winning training • benefits focused on the health and wellbeing of our employees