Job Title: Pharmacovigilance Product Analyst
We are seeking a highly skilled Pharmacovigilance Product Analyst to join our team. As a key member of our organization, you will play a critical role in ensuring the accuracy and efficiency of adverse event reporting.
* Product Ownership & Roadmap:
o Oversight of end-to-end product roadmaps to ensure alignment with business needs.
o Management of platform maintenance, rebuilding, and tech stack upgrades.
o Stay up-to-date on the latest pharmacovigilance and product technology trends.
* Cross-Functional Collaboration:
o Close collaboration with Business, Infrastructure, and Leadership teams to plan and manage product releases, downtime, incidents, and upgrades.
o Servicing as a key liaison across regulatory, clinical operations, QA, and IT functions.
* System Integration & Compliance:
o Overseeing safety system integrations to ensure accurate data flow and reporting.
o Ensuring Argus acts as the central system for receiving case data from call centers, flowing through safety systems, and reaching regulatory authorities with compliance documentation.
o Supporting signal detection and reporting in line with global compliance and regulatory standards.
* Monitoring, Debugging & Quality:
o Performing monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
o Reviewing AWS logs and system access for issue resolution.
o Collaborating with QA for system quality checks, validation, and signal monitoring.
* Analysis & Documentation:
o Gathering and analyzing requirements for PV systems and workflows.
o Documenting processes, data flows, and system functionalities related to adverse event reporting.
o Supporting validation and user acceptance testing (UAT).
This is a challenging yet rewarding role that requires strong analytical, problem-solving, and communication skills. If you are passionate about pharmacovigilance and have experience working in regulated environments, we encourage you to apply.
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.
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.