Solutions Specialist - SME - Pharmacovigilance

Solution Lead – Subject Matter Expert - Pharmacovigilance Safety Systems (PV)

• Location: United States
• Experience: 12 years
• Employment Type: Full-Time

Company Overview:

Our client is a rapidly growing leader in Pharmacovigilance (PV) Technology Solutions, offering tailored solutions that enhance compliance, improve operational efficiency, and reduce risk. Their expertise combines life sciences knowledge, system integration, and advanced technology to address critical PV challenges.

Position Overview:

We are seeking a high-impact Subject Matter Expert with expertise in Pharmacovigilance and Safety Systems to give the solutions.

The ideal candidate will be an expert in Pharmacovigilance business processes and Safety Systems configuration, with extensive experience in global PV regulations and requirements analysis. They should also have a strong understanding of technology, data migration, and BI reporting as they relate to PV systems, with the ability to oversee end-to-end processes and ensure compliance. This role offers opportunities for growth into senior leadership positions as the company expands globally.

Why Join Us?

Join a dynamic, people-centric environment that values ownership and accountability. We offer a nurturing culture that provides opportunities for growth and development, recognizing your contributions based on merit. You will be part of a team with decades of experience in life sciences, working on impactful projects that shape the future of industry. Collaborate with innovative technologies, drive change, and grow your career with us. Enjoy professional development, leadership opportunities, and the chance to make a real difference in a fast-evolving field.

Key Responsibilities:

Expertise in PV Business Processes and Safety Systems Configuration: Combine deep knowledge of Pharmacovigilance business processes with hands-on expertise in configuring PV systems (e.g., Oracle Argus Safety) to ensure that systems are aligned with both operational needs and regulatory requirements. Drive system configurations to optimize performance, data accuracy, and compliance.

Requirements Gathering & Analysis: Collaborate with stakeholders to gather and analyze system requirements, ensuring tailored configurations that meet both business and regulatory demands.

Knowledge of Global PV Regulations: Ensure compliance with regulations from major health authorities (e.g., MHRA, EMA, FDA, TGA, Health Canada, PMDA) through proper system configuration and governance.

Governance & Oversight: Provide strategic guidance on safety system updates, driving alignment with evolving business goals and regulatory standards. Lead cross-functional teams in implementing system changes and ensuring ongoing compliance.

Workflow Optimization: Continuously assess and improve system workflows to enhance efficiency and streamline operations in line with PV best practices.

Regulatory Reporting: Oversee the development of key reports, such as Aggregate Reports, Signal Detection, and KPIs, ensuring compliance with global PV regulations.

Technology Understanding: Possess a strong understanding of the technologies involved in Pharmacovigilance systems, particularly in relation to system configurations, data handling, and integration with other enterprise platforms. While not an expert-level requirement, the candidate should understand how these systems fit within the broader technology ecosystem of a PV organization.

Data Migration: Have a foundational understanding of data migration processes related to safety systems, ensuring seamless transitions between systems and accurate data transfers. Provide insights into how data migration impacts system configurations and business processes.

BI Reporting & Analytics: Have a working knowledge of Business Intelligence (BI) reporting and analytics, ensuring that system configurations support effective reporting, including compliance and safety performance dashboards. Understand how BI tools are integrated with safety systems for real-time monitoring and reporting.

Qualifications & Experience:

Education:

• Bachelor’s degree in Health Care / Life Sciences / Pharma , or related field

Experience:

• 12 years of proven experience as Solution specialist or SME within the pharmaceutical industry/ Life Sciences, preferably in Pharmacovigilance or Safety Systems.

Domain Expertise:

• Strong knowledge of pharmacovigilance regulations and experience with leading safety systems (e.g., Argus, ArisG, LifeSphere).
• Familiarity with AI/ML applications in safety systems and SaaS/cloud-based platforms.

What We Offer:

• Competitive Compensation Package – Base salary with performance-based incentives.
• Career Growth Opportunities – Fast-track to senior leadership.
• Impact-Driven Culture – Be part of a mission-driven organization making a difference in pharmacovigilance.

Ready to Make an Impact?

If you’re a go-getter with an entrepreneurial spirit and a passion for driving business growth, we’d love to hear from you!

Apply Now!

Submit your resume and cover letter outlining your relevant experience in Business Development within the Pharmacovigilance sector.

Let’s redefine the future of Pharmacovigilance Safety Systems—together!