Job Title: Pharmacovigilance Product Specialist
About the Role
We are seeking a highly skilled Pharmacovigilance Product Specialist to play a critical role in ensuring the accuracy and compliance of adverse event reporting. As a key member of our team, you will be responsible for overseeing end-to-end product roadmaps, ensuring alignment with business needs, and driving platform upgrades, integrations, and compliance.
Main Responsibilities
* Develop and manage the PV product roadmap, ensuring alignment with business priorities.
* Oversee platform maintenance, rebuilding, and tech stack upgrades (e.g., cloud migration).
* Stay updated on latest pharmacovigilance and product technology trends (AWS, GenAI, SaaS solutions).
* Cross-Functional Collaboration: Work closely with Business, Infrastructure, and Leadership teams to plan/manage product releases, downtime, incidents, and upgrades.
* Serve as the key liaison across regulatory, clinical operations, QA, and IT functions.
* System Integration & Compliance: Oversee safety system integrations (Argus, ArisG, Veeva Vault Safety) ensuring accurate data flow and reporting.
* Ensure Argus acts as the central system, receiving case data from call centers, flowing through safety systems, and reaching regulatory authorities with compliance documentation.
* Support signal detection and reporting in line with global compliance and regulatory standards (e.g., FDA, EMA, MHRA, GXP, CFR).
* Monitoring, Debugging & Quality: Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
* Review AWS logs and system access for issue resolution.
* Collaborate with QA for system quality checks, validation, and signal monitoring.
* Analysis & Documentation: Gather and analyze requirements for PV systems and workflows.
* Document processes, data flows, and system functionalities related to adverse event reporting.
* Support validation and user acceptance testing (UAT).
* Provide user training, support, and knowledge sharing.
Requirements
* 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.
Preferred 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.
Benefits
This role offers a unique opportunity to work with a talented team and contribute to the success of our organization.