Veeva Safety

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 Vault Safety in line with the overall drug development
process.
Participate in cross-functional team meetings to discuss safety data, trends, and potential risks.
Contribute to the continuous improvement of pharmacovigilance processes and systems..

Qualifications

3-10 years of experience.
Bachelor's or Master's degree in Pharmacy, Nursing, Life Sciences, or related field.
Extensive experience in pharmacovigilance and drug safety, preferably with Veeva Vault Safety or similar systems.
Strong understanding of global pharmacovigilance regulations and reporting requirements.
Excellent analytical and problem-solving skills.
Proficient in data management and analysis.
Strong communication and interpersonal skills.
Ability to work independently and collaboratively in a team environment..