Pharmacovigilance Business Analyst Role Summary
This is a key liaison position between business users, regulatory teams, and IT, ensuring that pharmacovigilance systems and workflows support accurate and compliant adverse event reporting.
Job Description:
The Pharmacovigilance Business Analyst (PharmaCov BA) will maintain patient safety, regulatory compliance, and efficient safety operations by working across teams to gather requirements, implement solutions, and provide support for pharmacovigilance systems.
* Gather and analyze requirements for pharmacovigilance systems and workflows.
* Work with business users, regulatory teams, and IT to implement or enhance safety systems.
* Document business processes, data flows, and system functionalities related to adverse event reporting.
* Ensure compliance with global regulatory standards.
* Support validation and user acceptance testing of PV systems.
* Provide support and training to end-users on safety systems and processes.
Required Skills and Qualifications:
Bachelor's degree in a relevant field. In-depth knowledge of pharmacovigilance processes and regulatory requirements. Experience working with safety systems such as Argus, ArisG, Veeva Vault Safety. Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities.
* Certification in pharmacovigilance.
* Experience with validation and user acceptance testing of PV systems.
Benefits:
Familiarity with adverse event reporting workflows and compliance processes. Understanding of global pharmacovigilance regulations.
* Hands-on experience with pharmacovigilance safety systems.
* Ability to use documentation and reporting tools to support system analysis and validation.