Pharmacovigilance Business Analyst
As a critical liaison between business stakeholders, regulatory teams, and IT specialists, the successful candidate will ensure that pharmacovigilance systems and workflows support accurate and compliant adverse event reporting, maintaining patient safety, regulatory compliance, and efficient safety operations.
Key Responsibilities:
* Gather and analyze requirements for pharmacovigilance systems and workflows
* Collaborate with business users, regulatory teams, and IT to implement or enhance safety systems, e.g., Argus, ArisG, Veeva Vault Safety
* Document business processes, data flows, and system functionalities related to adverse event reporting
* Ensure compliance with global regulatory standards, e.g., FDA, EMA, MHRA
* Support validation and user acceptance testing of PV systems
* Provide support and training to end-users on safety systems and processes
* Collaborate with cross-functional teams, including regulatory affairs, clinical operations, and IT
To succeed in this role, candidates must possess a Bachelor's degree in a relevant field, such as Life Sciences, Pharmacy, or IT, as well as in-depth knowledge of pharmacovigilance processes and regulatory requirements. Experience working with safety systems, such as Argus, ArisG, Veeva Vault Safety, is also essential. Additionally, strong analytical and problem-solving skills are required.
Desirable skills include certification in pharmacovigilance, experience with validation and user acceptance testing of PV systems, hands-on experience with pharmacovigilance safety systems, and familiarity with adverse event reporting workflows and compliance processes.