Pharmacovigilance Product Specialist
* The Pharmacovigilance Product Specialist will ensure pharmacovigilance systems and workflows enable accurate, compliant, and efficient adverse event reporting.
* Key Responsibilities:
o Product Roadmap Oversight: align end-to-end product roadmaps with business needs for seamless execution.
* Platform Management:
o Maintenance, rebuilding, and tech stack upgrades (e.g., CloudX to KCloud migration) to maintain optimal system performance.
* Tech Trends Monitoring:
o Stay updated on the latest pharmacovigilance and product technology trends (AWS, GenAI, SaaS solutions).
* Cross-functional Collaboration:
o Collaborate with Business, Infrastructure, and Leadership teams for planning/managing product releases, downtime, incidents, and upgrades.
* System Integration and Compliance:
o Oversee safety system integrations (Argus, ArisG, Veeva Vault Safety) ensuring accurate data flow and reporting.
* Compliance Documentation:
o Ensure Argus acts as the central system, receiving case data from call centers, flowing through safety systems, and reaching regulatory authorities with compliance documentation.
* Signal Detection and Reporting:
o Support signal detection and reporting in line with global compliance and regulatory standards (e.g., FDA, EMA, MHRA, GXP, CFR).
* Monitoring and Debugging:
o Perform monitoring and debugging for system issues such as unprocessed cases, reconciliation gaps, and data discrepancies.
* Quality Assurance:
o Collaborate with QA for system quality checks, validation, and signal monitoring.
* Analysis and Documentation:
o Gather and analyze requirements for PV systems and workflows.
* Process Documentation:
o Document processes, data flows, and system functionalities related to adverse event reporting.
* Validation Support:
o Support validation and user acceptance testing (UAT).
Qualifications:
* Bachelor's degree in Life Sciences, Pharmacy, Information Technology, or a 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.
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.
Estimated annual salary range: 83,475.00 - 144,425.00 BRL.