As a critical liaison between business stakeholders, regulatory experts, and IT professionals, the Pharmacovigilance Business Analyst plays a pivotal role in ensuring that pharmacovigilance systems and workflows support accurate and compliant adverse event reporting.
Key Responsibilities:
* Collect and analyze requirements for pharmacovigilance systems and workflows to guarantee seamless integration and effective operation.
* Collaborate with cross-functional teams, including regulatory affairs, clinical operations, 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 to facilitate informed decision-making.
* Evaluate compliance with global regulatory standards (e.g., FDA, EMA, MHRA) to mitigate risks and ensure adherence.
* Support validation and user acceptance testing of PV systems to ensure accuracy and reliability.
* Provide comprehensive training and support to end-users on safety systems and processes to enhance their proficiency.
* The ideal candidate will possess a Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, IT) and in-depth knowledge of pharmacovigilance processes and regulatory requirements.
The successful candidate will have experience working with safety systems such as Argus, ArisG, Veeva Vault Safety and demonstrate strong analytical and problem-solving skills.