Pharmacovigilance Business Analyst Role
The Pharmacovigilance Business Analyst plays a critical role in ensuring the effective and compliant management of adverse event reporting.
This position serves as a key liaison between business users, regulatory teams, and IT, fostering seamless collaboration to support accurate and efficient safety operations.
* Key Responsibilities:
* Gather and analyze requirements for pharmacovigilance systems and workflows.
* Work with cross-functional teams 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.
Requirements:
* Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, 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.
Tools and Technologies:
* Hands-on experience with pharmacovigilance safety systems such as Argus, ArisG, and Veeva Vault Safety.
* Familiarity with adverse event reporting workflows and compliance processes.
* Understanding of global pharmacovigilance regulations (e.g., FDA, EMA, MHRA).
* Ability to use documentation and reporting tools to support system analysis and validation.