Key Role: Pharmacovigilance Business Analyst
As a pharmacovigilance business analyst, you will serve as a key liaison between business users, regulatory teams, and IT to ensure that pharmacovigilance systems and workflows support accurate and compliant adverse event reporting. This role is critical in maintaining patient safety, regulatory compliance, and efficient safety operations.
Main Responsibilities:
* Gather and analyze requirements for pharmacovigilance systems and workflows.
* Collaborate with cross-functional teams including regulatory affairs, clinical operations, 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.
* Provide support and training to end-users on safety systems and processes.
Required Skills:
* Bachelor's degree in life sciences, pharmacy, or IT.
* 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.
Desirable Skills:
* Certification in pharmacovigilance.
* Experience with validation and user acceptance testing of PV systems.