Key Position Summary
The Pharmacovigilance Business Analyst will serve as a crucial liaison between business stakeholders, regulatory departments, and IT teams to ensure pharmacovigilance systems and workflows effectively support accurate and compliant adverse event reporting.
This role is critical in maintaining patient safety, regulatory compliance, and efficient safety operations. As a key position, the candidate will be responsible for several core duties:
1. Collect and analyze requirements for pharmacovigilance systems and workflows.
2. Collaborate with business users, regulatory teams, and IT professionals to implement or enhance safety systems (e.g., Argus, ArisG, Veeva Vault Safety).
3. Develop and document detailed knowledge of business processes, data flows, and system functionalities related to adverse event reporting.
4. Evaluate and maintain compliance with global regulatory standards (e.g., FDA, EMA, MHRA). The individual will also be responsible for evaluating the effectiveness of our current systems and providing recommendations for improvement.
5. Provide assistance and training to end-users on safety systems and processes.
6. Facilitate collaboration with cross-functional teams including regulatory affairs, clinical operations, and IT.
Responsibilities Key Responsibilities:
Gathering Requirements
* Identify and gather all necessary information regarding pharmacovigilance systems and workflows.
Implementing Solutions
* Work closely with various teams to design, develop, and deploy enhanced safety systems.
Documentation
* Document comprehensive information about business processes, data flows, and system functionalities.
Regulatory Compliance
* Maintain awareness of regulatory updates and changes across multiple regions.
Training Support
* Develop and deliver engaging training programs for end-users.
Cross-Functional Teamwork
* Ensure seamless communication and collaboration among different departments.
Professional qualifications and skills required include: Strong Communication and Collaboration Skills, Proficiency in Microsoft Office tools, Familiarity with ADaM and CDISC standardization for submission documentation.