Principal Pharmacovigilance SME

New York, United States | Posted on 02/20/2026

YD Talent Solutions (YDTS), founded in 2005, is a boutique firm delivering innovative talent acquisition and staffing solutions through advanced software platforms, specializing in Global Capability Centre deployment, onshore, nearshore, and offshore talent solutions.

YDTS provides strategic recruitment, Recruitment Process Outsourcing (RPO), staff augmentation, and talent lifecycle management while maintaining rigorous standards of quality and reliability recognized by partners worldwide.

By challenging conventional hiring models, YDTS empowers organizations to navigate complex talent acquisition challenges confidently with agile, high-impact workforce strategies tailored to modern global business demands.

About Our Client:

Our client is a leading provider of Pharmacovigilance Technology Solutions. They bring deep expertise in drug safety, paired with advanced technology, including AI and GenAI. Their innovative solutions tackle the most pressing challenges in the pharmaceutical industry. These solutions drive both operational efficiency and enhanced business performance.

Their offerings include proprietary products for automated case intake,advanced reporting platforms, GenAI-based solutions, and expert services suchas Business Transformation, Safety Systems Consulting (Argus, ArisG), Data Migration, and Computer System Validation. These flexible and scalablesolutions are designed to meet the needs of both large global companies and smaller organizations across diverse markets. With a focus on improving data accuracy, optimizing workflows, and ensuring patient safety, their solutions enable clients to address regulatory requirements while reducing operational costs.

By streamlining complex safety processes, they empower pharmaceutical companies to drive lasting business value and maintain a competitive edge in arapidly evolving industry.

Position Overview:

• Position: Principal / Associate Director / Solution Lead – Pharmacovigilance (PV)
  SME
• Experience: 15+ years

Key Roles and Responsibilities:

• Expertise in PV Business Processes and Safety Systems Configuration: Combine deep knowledge of Pharmacovigilance business processes withhands-on expertise in configuring PV systems (e.g., Oracle Argus Safety) toensure 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 togather and analyze system requirements, ensuring tailored configurations thatmeet 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 anexpert-level requirement, the candidate should understand how these systems fitwithin the broader technology ecosystem of a PV organization.
• Data Migration: Have a foundational understanding of data migration processes related tosafety systems, ensuring seamless transitions between systems and accurate data transfers. Provide insights into how data migration impacts the system configurations and business processes.
• BI Reporting & Analytics: Have a working knowledge of Business Intelligence (BI) reporting and…