Principal Pharmacovigilance SME

Principal / Associate Director / Solution Lead Pharmacovigilance (PV) SME

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 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 Key Roles and 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. Behavioral Skills: Stakeholder Engagement: Engage effectively with cross-functional teams, regulatory bodies, and external stakeholders to ensure alignment on system requirements. Leverage strong communication and negotiation skills to manage stakeholder expectations and align configurations with business goals. Adaptability: Quickly respond to changes in regulatory standards and business needs in a fast-paced environment. Demonstrate flexibility in adjusting to new challenges and evolving demands in the PV landscape. Leadership: Provide leadership in cross-functional projects, mentor junior team members, and support strategic decision-making. Guide teams through system implementations and improvements, ensuring alignment with business objectives. Critical Thinking: Apply strong analytical skills to solve complex configuration challenges while ensuring regulatory and business objectives are met. Proactively identify potential issues and develop solutions that maintain system integrity and compliance.

Ideal Candidate Profile: 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 Our Client: 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. Benefits 401 K Medical