Pharmacovigilance Product Analyst Position
The successful candidate will combine product ownership responsibilities with in-depth expertise in pharmacovigilance, regulatory compliance, and technology to serve as a strategic liaison between business users, regulatory teams, and IT.
Key Responsibilities:
* Product Roadmap Management: The Pharmacovigilance Product Analyst will be responsible for owning and managing the PV product roadmap, ensuring alignment with business priorities.
* Cross-Functional Collaboration: This role involves working closely with Business, Infrastructure, and Leadership teams to plan and manage product releases, downtime, incidents, and upgrades.
* System Integration & Compliance: The analyst will oversee safety system integrations (Argus, ArisG, Veeva Vault Safety), ensuring accurate data flow and reporting.
* Monitoring, Debugging & Quality: Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
* Analysis & Documentation: Gather and analyze requirements for PV systems and workflows. Document processes, data flows, and system functionalities related to adverse event reporting.
Requirements and Qualifications:
* Bachelor's degree in Life Sciences, Pharmacy, Information Technology, or a related field.
* Strong experience as a Product Analyst or Business Analyst in a regulated environment.
* Proven knowledge of pharmacovigilance processes and regulatory requirements.
* Hands-on experience with PV safety systems such as Argus, ArisG, Veeva Vault Safety.
* Strong analytical, problem-solving, and documentation skills.
Key Skills and Tools:
* PV systems: Argus, ArisG, Veeva Vault Safety.