Job Description
Key Responsibilities
- Oversee the operation and maintenance of the Veeva Vault Safety system.
- Configure and customize the system to fit organizational needs and regulatory requirements.
- Implement and manage workflows for adverse event reporting, risk management, and safety data analysis.
- Ensure Veeva Vault Safety system compliance with global pharmacovigilance regulations (such as FDA, EMA, ICH guidelines).
- Prepare and submit periodic safety reports and other regulatory documents as required.
- Stay updated with regulatory changes and implement necessary system updates. Data Management and Analysis:
- Manage the collection, processing, and analysis of safety data.
- Develop and generate safety reports for internal and external stakeholders.
- Ensure the integrity and confidentiality of safety data.
- Work closely with clinical, regulatory, and IT teams to optimize the use of Veeva V...
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