Manager, Pharmacovigilance Safety Writing

Manager, Pharmacovigilance Safety Writing

Join Thermo Fisher Scientific as a Safety Writing Manager and lead drug safety operations. Ensure patient safety and regulatory compliance in clinical trials by managing and optimizing these critical processes.

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 developmental and marketed products.
• Ensure the team has adequate resources to deliver services according to company policies, contractual agreements, and applicable regulations.
• Maintain effective communication with other functional groups regarding safety writing activities.
• Prepare and present proposals and bids for the Safety Writing Team.
• Participate in client and internal meetings, audits, and regulatory authority inspections.
• Engage in departmental initiatives and task forces for process improvement and department management.
• Stay updated on current regulations and practices by reviewing regulatory/pharmacovigilance publications.
• Provide input on Pharmacovigilance procedural documents.
• Participate in meetings to discuss quality, budgetary, or operational aspects of safety writing services.
• Manage a team of experienced professionals, including interviewing, hiring, professional development, goal setting, performance management, coaching, mentoring, employee counseling, and separations.
• Approve salary administration, hiring decisions, corrective actions, and terminations.
• Review and approve time records, expense reports, and leave requests.

Education and Experience:

• Bachelor's or higher scientific degree.
• Over 5 years of previous safety writing experience.
• 1+ year of leadership responsibility.
• An equivalent combination of education, training, and experience may be considered.

Knowledge, Skills and Abilities:

• Excellent knowledge of risk management plans and ICH/US aggregate safety reporting formats for clinical trials and marketed products.
• Exceptional attention to detail, data interpretation, and medical-scientific writing skills.
• Proficient time management and project management skills.
• Proficiency in Microsoft Office products and safety databases.
• Excellent oral and written English communication skills.
• Strong attention to detail and accuracy.
• Excellent critical thinking, problem-solving, and decision-making abilities.
• Advanced understanding of global regulatory requirements for pharmacovigilance and compliance with procedural documents and regulations.

Working Conditions and Environment:

• Office environment with standard office equipment.
• Daily exposure to high pressure and intense concentration.
• Daily interactions with clients and associates.
• Occasional long and varied hours.
• Occasional domestic and/or international travel required.

Why Join Us?

Become part of a global team at Thermo Fisher Scientific that values passion, innovation, and scientific excellence. Experience an environment where collaboration and development foster everyday growth, and your contributions make a significant impact. Apply today to help us deliver tomorrow's breakthroughs.

Key skills/competency

• Pharmacovigilance
• Safety Writing Manager
• Aggregate Safety Reports
• Risk Management Plans (RMPs)
• Regulatory Compliance
• Clinical Trials
• ICH Guidelines
• Team Management
• Medical Writing
• Regulatory Affairs