Drug Safety Specialist

Position Overview

• Location Type: Not specified
• Employment Type: Full-time
• Work Schedule: Standard (Mon-Fri)
• Job Type: Safety Specialist
• Salary: Not specified

About the Role: Join Thermo Fisher Scientific Inc. as a Safety Specialist in a dynamic team. Contribute to maintaining high safety standards in Pharmacovigilance.

Responsibilities

• Performs day-to-day PV activities.
• May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures, and proposals.
• Maintains medical understanding of applicable therapeutic area and disease states.
• Reviews cases entered for quality, consistency, and accuracy, including review of peer reports.
• Prepares and maintains regulatory safety reports.
• Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.
• Mentors less experienced staff.

Job Complexity

• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
• Exercises judgment within defined procedures and practices to determine appropriate action.

Business Relationships

• Contacts are primarily internal to the company with infrequent external customer/vendor contact on routine matters.
• Builds productive internal/external working relationships.

Requirements

• Proven experience in Pharmacovigilance or a related field.
• General understanding of pathophysiology and the disease process.
• Detailed knowledge of relevant therapeutic areas as required for processing AEs.
• Strong critical thinking and problem-solving skills.
• Good oral and written communication skills including paraphrasing skills.
• Good command of English and ability to translate information into local language where required.
• Computer literate with the ability to work within multiple databases.
• Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel).
• Understanding the importance of and compliance with procedural documents and regulations.
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision.
• Strong attention to detail.
• Ability to maintain a positive and professional demeanor in challenging circumstances.
• Ability to work effectively within a team to attain a shared goal.

Why Join Us?

• At Thermo Fisher Scientific, we provide a dynamic and inclusive work environment where your contributions are valued.
• We are committed to driving technological innovation and supporting patients in need.