Job Description

　　Provides administrative safety support to the safety reporting team and Pharmacovigilance department. Responsible for tasks related to receipt and submission of expedited and periodic safety reports, including quality check tasks, pertaining to the department’s projects. Assists management in producing project metrics as required. Involved in projects and programs relating to safety reporting and may take a lead role on projects.

　　Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues.

　　May also be involved in updates to procedures and other initiatives related to safety reporting.

　　May mentor or train new central safety reporting staff.

　　A day in the Life:

　　Receives, prepares, and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation.

　　Assists in producing metrics and alerts manager to any quality or timeline issues.

　　Ensures timely maintenance of safety reporting systems and information.

　　Liaises with various departments and external parties (including clients) in relation to safety reporting tasks and the setting up and maintenance of projects.

　　Good understanding of SOPs, GDs and project related documentation.

　　Proactively troubleshoots daily operational issues with limited input from management.

　　With support of management, provides updates to the operational safety reporting team and Senior Management in relation to work deliverables / status as required and in accordance with regulatory requirements.

　　Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives.

　　Responsible for training Pharmacovigilance department staff on the safety reporting process and various systems associated with safety reporting.

　　Assists with, and may participate in, audit and inspection preparation if required or requested by the company or client.

　　Knowledge of, and ability to perform against, KPIs for projects.

　　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.