Pharmacovigilance Product Analyst Job Description
The role of Pharmacovigilance Product Analyst is critical in ensuring that pharmacovigilance systems and workflows enable accurate, compliant, and efficient adverse event reporting. This position serves as a strategic liaison between business users, regulatory teams, and IT.
Key Responsibilities:
* Develop and manage the product roadmap to align with business priorities.
* Oversee platform maintenance, rebuilding, and tech stack upgrades.
* Stay updated on the latest pharmacovigilance and product technology trends.
* Collaborate cross-functionally with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.
The ideal candidate will possess a strong background in pharmacovigilance processes and regulatory requirements, hands-on experience with PV safety systems, and 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.