Adverse Event Reporting Specialist
As an Adverse Event Reporting Specialist, you will serve as a strategic liaison between business users, regulatory teams, and IT. Your goal is to ensure pharmacovigilance systems and workflows enable accurate, compliant, and efficient adverse event reporting.
This role combines strong product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology. You will oversee end-to-end product roadmaps, ensuring alignment with business needs, and drive platform upgrades, integrations, and compliance.
* You will own and manage the PV product roadmap, ensuring alignment with business priorities.
* You will oversee platform maintenance, rebuilding, and tech stack upgrades.
* You will stay updated on latest pharmacovigilance and product technology trends.
Additionally, you will work closely with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades. You will serve as the key liaison across regulatory, clinical operations, QA, and IT functions.
You will also be responsible for overseeing safety system integrations, ensuring accurate data flow and reporting. You will support signal detection and reporting in line with global compliance and regulatory standards.
Your analysis skills will come into play when performing monitoring and debugging for system issues. You will review AWS logs and system access for issue resolution and collaborate with QA for system quality checks, validation, and signal monitoring.
In this role, you will gather and analyze requirements for PV systems and workflows. You will document processes, data flows, and system functionalities related to adverse event reporting. You will also provide user training, support, and knowledge sharing.
Required skills include familiarity with AWS (for RCA/debugging), Cloud/SaaS platforms, experience with JIRA for incident/release management, and experience with validation and UAT in regulated environments. Strong experience as a Product Analyst or Business Analyst in a regulated environment is required. Proven knowledge of pharmacovigilance processes and regulatory requirements is necessary.
Key qualifications:
* Bachelor's degree in Life Sciences, Pharmacy, Information Technology, or related field.
* Excellent problem-solving and analytical skills.
* Ability to communicate complex ideas effectively.