Pharmacovigilance Manager

About the role

Join us as Manager PVG 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.

Responsibilities

• Manage multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements.
• Maintain good communications with other functional groups concerning program and company issues.
• Collaborate with other employees in problem solving and systems improvement.
• Review regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, procedures and proposals.
• Maintain a basic medical understanding of applicable therapeutic areas and disease states.
• Participate in on‑call duties for specific projects and ensure 24‑hour coverage for intake of cases from investigative sites.
• Provide plans and accurate forecasts for all projects.
• Serve as a resource for other departmental managers and lead departmental initiatives.
• Prepare and present proposals.
• Manage staff of experienced professionals, including interviewing, selection, job description preparation, professional development, goal setting, performance management, coaching, 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.

Requirements

• Bachelor’s degree or equivalent with relevant formal academic/vocational qualification and at least 3 years of safety experience.
• Comparable experience providing the knowledge, skills, and abilities to perform the job (approximately 5 + years).
• At least 1 year of leadership responsibility.
• Equivalency may be considered through a combination of appropriate education, training, and directly related experience.

Knowledge, Skills, and Abilities

• Experience managing professionals and/or subordinate managers who exercise latitude and independence; often heads one or more sections or a small department.
• Working knowledge of global regulatory requirements and compliance with procedural documents.
• Strong knowledge of relevant therapeutic areas required for processing adverse events.
• General knowledge of pathophysiology and disease processes.
• Time management and project management skills.
• Proficiency 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 attention to detail and accuracy.
• Strong critical thinking, problem‑solving, and decision‑making skills.

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.