Job Title: Pharmacovigilance Business Analyst
The Pharmacovigilance Business Analyst serves as a key liaison between business users, regulatory teams, and IT, ensuring pharmacovigilance systems and workflows support accurate and compliant adverse event reporting. This role is critical in maintaining patient safety, regulatory compliance, and efficient safety operations.
Key Responsibilities:
* Gather and Analyze Requirements: Gather and analyze requirements for pharmacovigilance systems and workflows.
* Implement or Enhance Safety Systems: Work with business users, regulatory teams, and IT to implement or enhance safety systems (e.g., Argus, ArisG, Veeva Vault Safety).
* Document Business Processes: Document business processes, data flows, and system functionalities related to adverse event reporting.
* Ensure Compliance: Ensure compliance with global regulatory standards (e.g., FDA, EMA, MHRA).
* Support Validation and Testing: Support validation and user acceptance testing of PV systems.
* Provide Training and Support: Provide support and training to end-users on safety systems and processes.
* Cross-Functional Collaboration: Collaborate with cross-functional teams including regulatory affairs, clinical operations, and IT.
Qualifications:
* Bachelor's Degree: Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, IT).
* Pharmacovigilance Knowledge: In-depth knowledge of pharmacovigilance processes and regulatory requirements.
* Safety System Experience: Experience working with safety systems such as Argus, ArisG, Veeva Vault Safety.
* Strong Analytical Skills: Strong analytical and problem-solving skills.
* Excellent Communication Skills: Excellent communication and interpersonal abilities.
* Collaborative Ability: Ability to work collaboratively in cross-functional teams.
Desirable Skills:
* Certification: Certification in pharmacovigilance.
* Validation and Testing Experience: Experience with validation and user acceptance testing of PV systems.
Tools and Technologies:
* Hands-on Experience: Hands-on experience with pharmacovigilance safety systems such as Argus, ArisG, and Veeva Vault Safety.
* Familiarity with Workflows: Familiarity with adverse event reporting workflows and compliance processes.
* Regulatory Understanding: Understanding of global pharmacovigilance regulations (e.g., FDA, EMA, MHRA).
* Documentation Tools: Ability to use documentation and reporting tools to support system analysis and validation.