Drug Safety Reporting Senior

hace 2 meses


Desde casa, México Thermo Fisher Scientific A tiempo completo

Receives, prepares, and submits safety reports to applicable parties. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis.
- Identifies and resolves any quality or timeline issues and keeps the Manager informed of progress.
- Exercises independent judgment to troubleshoot, resolves project issues and identifies areas for improvement. o
- Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines.
- Provides input and feedback to aid the development of program and departmental procedural documents.
- Shares ideas and suggestions with team members. Takes an active role in the development and implementation of ideas and suggestions.
- Attends and presents at various meetings as required.
- Facilitates and advises on company, client and regulatory audits where required.
- Provides training and support to lower-level team members, mentors new starters, provides input on individual performance and shares ideas and suggestions with team members.
- Works with the manager to collate metrics, analyzes compliance metrics and provides recommendations on updating financial systems.



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