The role of a Pharmacovigilance Business Analyst is to act as a vital link between business stakeholders, regulatory teams, and IT professionals ensuring that pharmacovigilance systems and workflows support accurate and compliant adverse event reporting thereby maintaining patient safety, regulatory compliance, and efficient safety operations.
Key responsibilities include gathering and analyzing requirements for pharmacovigilance systems and workflows working with cross-functional teams including regulatory affairs, clinical operations, and IT to implement or enhance safety systems documenting business processes data flows and system functionalities related to adverse event reporting ensuring compliance with global regulatory standards supporting validation and user acceptance testing of PV systems and providing training to end-users on safety systems and processes.
Qualifications required are a Bachelor's degree in a relevant field such as Life Sciences, Pharmacy, or Information Technology along with 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 and ability to work collaboratively in cross-functional teams.