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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    Summarized Purpose: 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 with allocation of work tasks to safety reporting team...


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    Essential Functions 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. Participates on...


  • Desde casa, México Thermo Fisher Scientific A tiempo completo

    **Summarized Purpose**: Provides administrative safety support to the Pharmacovigilance department. Specifically in relation to submissions, tracking and subsequent filing and archiving or expedited and periodic safety reports. This includes other general administration tasks such as filing, photocopying, typing and performing reconciliation tasks. Involved...


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    Job Description **Summarized Purpose**: Provides administrative safety support to the Pharmacovigilance department. Specifically in relation to submissions, tracking and subsequent filing and archiving or expedited and periodic safety reports. This includes other general administration tasks such as filing, photocopying, typing and performing reconciliation...


  • Desde casa, México Thermo Fisher Scientific A tiempo completo

    Job Description **Summarized Purpose**: Provides administrative safety support to the Pharmacovigilance department. Specifically in relation to submissions, tracking and subsequent filing and archiving or expedited and periodic safety reports. This includes other general administration tasks such as filing, photocopying, typing and performing reconciliation...


  • Desde casa, México Thermo Fisher Scientific A tiempo completo

    Receives, prepares, and submits safety reports to applicable parties. Escalates to lead and 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 the manager to quality or timeline issues. Participates in project teams and may lead...


  • Desde casa, México Thermo Fisher Scientific A tiempo completo

    Essential Functions 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. Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory...


  • Desde casa, México Thermo Fisher Scientific A tiempo completo

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