Job Description

　　Performs day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.

　　• Performs day-to-day PVG activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.

　　• Reviews regulatory/pharmacovigilancepublications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintain 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.

　　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.