Job Description – PV Manager Veeva
Qualifications
- 5-12 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..
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 c hanges 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..
Job Function
BUSINESS PROCESS SERVICES
Desired Skills
Veeva vault
Desired Candidate Profile
Qualifications : MASTER OF PHARMACY
