1 month ago

Manager, Pharmacovigilance Safety Writing

Thermo Fisher Scientific

Hybrid
Full Time
$120,000
Hybrid
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Job Overview

Job TitleManager, Pharmacovigilance Safety Writing
Job TypeFull Time
Offered Salary$120,000
LocationHybrid

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Job Description

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

Tags:

Pharmacovigilance
Safety Writing
Drug Safety
Regulatory Affairs
Clinical Trials
Manager
Team Lead
Medical Writing
ICH Guidelines
Risk Management
Aggregate Reports
Microsoft Office
Safety Databases
Problem Solving
Leadership

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How to Get Hired at Thermo Fisher Scientific

  • Tailor your resume: Highlight your 5+ years of safety writing and 1+ year of leadership experience, aligning keywords with the job description's requirements for pharmacovigilance and regulatory compliance.
  • Craft a compelling application: Clearly articulate your experience in managing aggregate safety reports, RMPs, and leading teams within a clinical trial or drug development context.
  • Prepare for interviews: Be ready to discuss your understanding of global regulatory requirements, ICH guidelines, and your approach to team management and process improvement.
  • Research Thermo Fisher Scientific: Understand their commitment to scientific excellence and how your role contributes to patient safety and delivering breakthroughs.

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