Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

Job Knowledge

Developing professional expertise, applies company policies and procedures to resolve a variety of issues. 

Supervision Received

Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercise 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 processDetailed knowledge of relevant therapeutic areas as required for processing AEsStrong critical thinking and problem solving skillsGood oral and written communication skills including paraphrasing skillsGood command of English and ability to translate information into local language where requiredComputer literate with the ability to work within multiple databasesPrevious exposure to Microsoft Office packages (including Outlook, Word, and Excel)Understanding the importance of and compliance with procedural documents and regulationsAbility to manage and prioritize a variety of tasks and meet strict deadlines with limited supervisionStrong attention to detailAbility to maintain a positive and professional demeanor in challenging circumstancesAbility 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. Join our team and assist us in successfully implementing solutions that have a global impact.