Job Description

Hi,

We are hiring for one of India's leading IT & consulting organizations for the position of PV VEEVA Role.

Summary

A PV (Pharmacovigilance) Veeva in healthcare refers to a role focused on drug safety monitoring, processing, and management using the Veeva Vault Safety cloud-based software. It involves identifying, assessing, and preventing adverse effects of medicines, utilizing Veeva's technology to automate and streamline these processes for pharmaceutical companies.

Key skills

• Minimum 5 years of experience in managing, operating, and ensuring compliance within Veeva Vault for pharmacovigilance processes.
• Extensive experience in pharmacovigilance and drug safety, preferably with Veeva Vault Safety or similar systems.
• Adherence Regulatory Compliance (FDA, EMA, ICH Guidelines)
• Bachelor or Masters degree in Pharmacy, Nursing, Life Sciences, or related field.

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.
• 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.
• 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.

More Info

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