**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 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. Join our team and assist us in successfully implementing solutions that have a global impact. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.