Pharmacovigilance Analyst Role Overview
">
Key Responsibilities:
">
* Strategic Product Owner: Oversight of End-to-End Product Roadmaps, Ensuring Alignment with Business Needs and Driving Platform Upgrades, Integrations, and Compliance.
">
Required Skills and Qualifications:
">
* Product Ownership and Roadmap: Ability to Manage PV Product Roadmaps, Ensuring Alignment with Business Priorities.
">
* Cross-Functional Collaboration: Strong Experience Working Closely with Business, Infrastructure, and Leadership Teams to Plan/Manage Product Releases, Downtime, Incidents, and Upgrades.
">
* System Integration and Compliance: Proficiency in Overseeing Safety System Integrations (Argus, ArisG, Veeva Vault Safety), Ensuring Accurate Data Flow and Reporting.
">
* Monitoring, Debugging, and Quality: Hands-On Experience Performing Monitoring and Debugging for System Issues Such as Unprocessed Cases, Reconciliation Gaps, and Data Discrepancies.
">
* Analysis and Documentation: Ability to Gather and Analyze Requirements for PV Systems and Workflows, Documenting Processes, Data Flows, and System Functionalities Related to Adverse Event Reporting.
">
* 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.
">
* Familiarity with AWS (for RCA/debugging), Cloud/SaaS Platforms.
">
* Experience with JIRA for Incident/Release Management.
">
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.
">
Skills:
">
Familiarity with AWS (for RCA/debugging), Cloud/SaaS platforms.
">
Experience with JIRA for incident/release management.
">
Tools & Technologies:
">
">
* PV systems: Argus, ArisG, Veeva Vault Safety.
">
Benefits:
This role offers a unique opportunity to combine product ownership responsibilities with deep domain expertise in pharmacovigilance, regulatory compliance, and technology.
">
As a Pharmacovigilance Analyst, you will be responsible for ensuring accurate, compliant, and efficient adverse event reporting by bridging the gap between business users, regulatory teams, and IT.
">
The ideal candidate will have strong experience working closely with business, infrastructure, and leadership teams to plan/manage product releases, downtime, incidents, and upgrades.
">
Additionally, you will oversee safety system integrations (Argus, ArisG, Veeva Vault Safety), ensuring accurate data flow and reporting.
">
Our company is committed to providing a supportive and collaborative work environment that fosters growth and development.
">
Others:
Please note that this job description may not include all aspects of the job. You may also be required to perform other duties as needed.
">
Apart from the job description above, please ensure you meet the minimum qualifications listed below before applying:
">
">
* Meet the minimum qualifications listed above.
">
">
By applying for this role, you acknowledge that you have read and understood the job description and minimum qualifications listed above.
">
We are an equal opportunities employer and welcome applications from all qualified candidates.
">
Thank you for your interest in our company!
"],