The Pharmacovigilance Product Analyst plays a key role in ensuring the accuracy and efficiency of adverse event reporting.
This strategic liaison position combines strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology. The successful candidate will be responsible for overseeing the safety system integrations (Argus, ArisG, Veeva Vault Safety) to ensure accurate data flow and reporting.
Key responsibilities include:
* Product Ownership & Roadmap: Owning and managing the PV product roadmap, ensuring alignment with business priorities.
* Cross-Functional Collaboration: Working closely with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.
* System Integration & Compliance: Overseeing safety system integrations (Argus, ArisG, Veeva Vault Safety) ensuring accurate data flow and reporting.
* Monitoring, Debugging & Quality: Performing monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
* Analysis & Documentation: Gathering and analyzing requirements for PV systems and workflows, documenting processes, data flows, and system functionalities related to adverse event reporting.
Qualifications:
* Bachelor's degree in Life Sciences, Pharmacy, Information Technology, or 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.
* Excellent communication and stakeholder management abilities.
Required Skills:
* Familiarity with AWS (for RCA/debugging), Cloud/SaaS platforms.
* Experience with JIRA for incident/release management.
* Experience with validation and UAT in regulated environments.
Tools & Technologies:
* PV systems: Argus, ArisG, Veeva Vault Safety.