Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.We hire the best, develop ourselves and each other, and recognise the power of being one team. We offer continued career advancement opportunities, award-winning training and benefits focused on the health and wellbeing of our employees.

A Day in the Life:

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 activites on assigned projects.

Essential Functions:

• 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. May participate in on-call duties for specific projects.
• Provides plans and accurate forecasts for all assigned projects.
• Serves as a resource to other departmental managers and leads departmental initiatives.
• 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.
• For assigned projects, serves as a safety scientist creator/contributor for signal detection, aggregate safety report writing and/or other product safety science tasks.

Keys to Success:

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification to include 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.
• 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.

Skills and Abilities:

• 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
• Excellent oral and written communication skills
• Strong critical thinking, problem solving and decision-making skills