Principal Pharmacovigilance SME

YD Talent Solutions•New York, NY

About The Position

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 such as Business Transformation, Safety Systems Consulting (Argus, ArisG), Data Migration, and Computer System Validation. These flexible and scalable solutions 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 a rapidly evolving industry. Position Overview: · Position: Principal / Associate Director / Solution Lead – Pharmacovigilance (PV) SME · Location: East Coast, USA · Experience: 15+ years

Requirements

Expertise in PV Business Processes and Safety Systems Configuration
Requirements Gathering & Analysis
Knowledge of Global PV Regulations
Governance & Oversight
Workflow Optimization
Regulatory Reporting
Technology Understanding
Data Migration
BI Reporting & Analytics
Stakeholder Engagement
Adaptability
Leadership
Critical Thinking

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 the 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.