Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

Join us as Safety Writing Manager – 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 the delivery of global aggregate safety reports, risk management plans (RMPs), regulatory authority assessment report responses, and custom safety reports, for both developmental and marketed products.

• Ensure that the team is provided with sufficient resources to deliver services in accordance with company policies and procedures, contractual agreements and applicable regulations.
• Maintain good communication with other functional groups concerning safety writing activities. • Prepare for and present proposals and bids on behalf of the Safety Writing Team.

• Prepare for and contribute to client and internal meetings, audits and regulatory authority inspections.

• Participate in departmental initiatives and task forces for process improvement and overall department management.
• Review regulatory/pharmacovigilance publications and information sources to keep updated on current regulations and practices.

• Provide input on PV procedural documents.

• Participate in meetings to communicate quality, budgetary or operational information in relation to safety writing services.
• 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 or higher scientific degree
• Previous safety writing experience to provide the knowledge, skills, and abilities to perform the job (> 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:
•  Excellent knowledge of risk management plans and ICH and US aggregate safety reporting formats relating to both clinical trials and marketed products

• Excellent attention to detail, data interpretation and medical-scientific writing skills 

• Time management and project management skills 
• Proficient in Microsoft Office products and safety databases 
• Excellent oral and written English language communication skills
• Strong attention to detail and accuracy 
• Strong critical thinking, problem solving and decision making skills

• Advanced understanding of the global regulatory requirements pertaining to pharmacovigilance and the importance of and compliance with procedural documents and regulations 

Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment
• Daily exposure to high pressure and intense concentration
• Daily interactions with clients/associates
• Long, varied hours on occasion
• Travel required occasionally domestic and/or international

Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough.