Pharmacovigilance Systems Analyst Role
The Pharmacovigilance Systems Analyst serves as a key liaison between stakeholders, regulatory teams, and IT to ensure pharmacovigilance systems are accurate, compliant, and efficient for adverse event reporting.
This role requires strategic collaboration with cross-functional teams to plan, manage, and execute product releases, downtime, incidents, and upgrades.
The successful candidate will oversee the development and maintenance of pharmacovigilance systems, ensuring data flow and compliance with regulatory requirements.
Key Responsibilities:
* System Development & Maintenance
* Developing and maintaining pharmacovigilance systems to ensure accurate and compliant adverse event reporting.
* Collaborating with IT teams to design, implement, and test system integrations.
* Regulatory Compliance
* Ensuring compliance with regulatory requirements for pharmacovigilance systems.
* Staying up-to-date with latest regulations and industry trends.
* Quality Assurance
* Performing quality assurance activities to ensure system accuracy and compliance.
* Reviewing system logs and access for issue resolution.
* Process Improvement
* Identifying areas for process improvement in pharmacovigilance systems.
* Developing and implementing process improvements to enhance system efficiency and compliance.
Requirements:
* Bachelor's degree in Life Sciences, Pharmacy, Information Technology, or related field.
* Strong experience as a Systems Analyst or Business Analyst in a regulated environment.
* Proven knowledge of pharmacovigilance processes and regulatory requirements.
* Hands-on experience with PV safety systems such as Argus, ArisG, Veeva Vault Safety.