[Hiring] Manager, PV - Safety Writing @Thermo Fisher Scientific

Role 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.

• 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.

Qualifications

• 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

Requirements

• 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

Benefits

• 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.