The Pharmacovigilance Business Analyst plays a pivotal role in maintaining patient safety and regulatory compliance.
This critical position serves as a liaison between business users, regulatory teams, and IT, ensuring pharmacovigilance systems support accurate and compliant adverse event reporting.
Key Responsibilities:
* 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 (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.
Required Qualifications:
* 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.
* Excellent communication and interpersonal abilities.
* Ability to work collaboratively in cross-functional teams.
Desirable Skills:
* Certification in pharmacovigilance.
* Experience with validation and user acceptance testing of PV systems.
Key Tools and Technologies:
* Hands-on experience with pharmacovigilance safety systems.
* Familiarity with adverse event reporting workflows and compliance processes.
* Understanding of global pharmacovigilance regulations.
* Ability to use documentation and reporting tools to support system analysis and validation.