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.

Job Description

About OurClient:

Our client is a leading provider of Pharmacovigilance TechnologySolutions. They bring deep expertise in drug safety, paired with advancedtechnology, including AI and GenAI. Their innovative solutions tackle the mostpressing challenges in the pharmaceutical industry. These solutions drive bothoperational 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), DataMigration, and Computer System Validation. These flexible and scalablesolutions are designed to meet the needs of both large global companies andsmaller organizations across diverse markets. With a focus on improving dataaccuracy, optimizing workflows, and ensuring patient safety, their solutionsenable clients to address regulatory requirements while reducing operationalcosts. By streamlining complex safety processes, they empower pharmaceuticalcompanies 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

Requirements

Key Roles and Responsibilities:

• Expertise in PV Business Processes and Safety SystemsConfiguration: 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 regulatoryrequirements. Drive system configurations to optimize performance, dataaccuracy, 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 regulationsfrom major health authorities (e.g., MHRA, EMA, FDA, TGA, Health Canada, PMDA)through proper system configuration and governance.
• Governance & Oversight: Provide strategic guidance on safetysystem updates, driving alignment with evolving business goals and regulatorystandards. Lead cross-functional teams in implementing system changes andensuring ongoing compliance.
• Workflow Optimization: Continuously assess and improve system workflows to enhance efficiencyand streamline operations in line with PV best practices.
• Regulatory Reporting: Oversee the development of key reports, such as Aggregate Reports, SignalDetection, and KPIs, ensuring compliance with global PV regulations.
• Technology Understanding: Possess a strong understanding of the technologies involved inPharmacovigilance 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 datatransfers. Provide insights into how data migration impacts the system configurations and business processes.
• BI Reporting & Analytics: Have a working knowledge of BusinessIntelligence (BI) reporting and analytics, ensuring that system configurationssupport effective reporting, including compliance and safety performancedashboards. Understand how BI tools are integrated with safety systems forreal-time monitoring and reporting.

BehavioralSkills:

• Stakeholder Engagement: Engage effectively with cross-functional teams, regulatory bodies, andexternal stakeholders to ensure alignment on system requirements. Leveragestrong communication and negotiation skills to manage stakeholder expectationsand align configurations with business goals.
• Adaptability: Quickly respond to changes in regulatory standards and business needs ina fast-paced environment. Demonstrate flexibility in adjusting to newchallenges and evolving demands in the PV landscape.
• Leadership: Provide leadership in cross-functional projects, mentor junior teammembers, and support strategic decision-making. Guide teams through systemimplementations and improvements, ensuring alignment with business objectives.
• Critical Thinking: Apply strong analytical skills to solve complex configuration challengeswhile ensuring regulatory and business objectives are met. Proactively identifypotential issues and develop solutions that maintain system integrity andcompliance.

Ideal Candidate Profile:

The ideal candidatewill be an expert in Pharmacovigilance business processes and Safety Systemsconfiguration, with extensive experience in global PV regulations andrequirements analysis. They should also have a strong understanding oftechnology, data migration, and BI reporting as they relate to PV systems, withthe ability to oversee end-to-end processes and ensure compliance. This roleoffers opportunities for growth into senior leadership positions as the companyexpands globally.

WhyJoin Our Client:

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

401 K

Medical

YD Talent Solutions is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.

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