Pharmacovigilance Business Analyst Job Description
The Pharmacovigilance Business Analyst plays a vital role in bridging the gap between business users, regulatory teams, and IT departments. This individual ensures that pharmacovigilance systems and workflows accurately capture and report adverse events.
This position is crucial in maintaining patient safety and regulatory compliance while optimizing safety operations.
* Collect and analyze requirements for pharmacovigilance systems and workflows.
* Collaborate with stakeholders to implement or enhance safety systems.
* Document business processes, data flows, and system functionalities related to adverse event reporting.
* Ensure adherence to global regulatory standards.
* Support validation and user acceptance testing of PV systems.
* Provide training and support to end-users on safety systems and processes.
* Work closely with cross-functional teams including regulatory affairs, clinical operations, and IT.
Required Skills and Qualifications:
* Bachelor's degree in a relevant field such as life sciences, computer science, or healthcare management.
* In-depth knowledge of pharmacovigilance processes and regulatory requirements.
* Experience working with safety systems and adverse event reporting tools.
* Strong analytical and problem-solving skills.
* Excellent communication and interpersonal abilities.
* Ability to work collaboratively in cross-functional teams.
Desirable Skills:
* Certification in pharmacovigilance such as RAPS or ISPE.
* Experience with validation and user acceptance testing of PV systems.
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.