Senior Pharmacovigilance Director

5 days ago

Jersey City, New Jersey, United States YD Talent Solutions Full time

About Our Company:

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

Position Overview:

Position: Senior Pharmacovigilance Director

Location: East Coast USA

Experience: 15 years



Key Responsibilities:

Expertise in PV Business Processes and Safety Systems Configuration:

  • Combine deep knowledge of Pharmacovigilance business processes with handson expertise in configuring PV systems (e.g. Oracle Argus Safety) to ensure that systems are aligned with both operational needs and regulatory requirements.
  • 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 crossfunctional 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.
  • Data Migration: Have a foundational understanding of data migration processes related to safety systems ensuring seamless transitions between systems and accurate data transfers.
  • 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.

Behavioral Skills:

  • Stakeholder Engagement: Engage effectively with crossfunctional teams regulatory bodies and external stakeholders to ensure alignment on system requirements.
  • Adaptability: Quickly respond to changes in regulatory standards and business needs in a fastpaced environment.
  • Leadership: Provide leadership in crossfunctional projects mentor junior team members and support strategic decisionmaking.
  • Critical Thinking: Apply strong analytical skills to solve complex configuration challenges while ensuring regulatory and business objectives are met.


Why Work with Us:

YD Talent Solutions offers a dynamic peoplecentric environment that values ownership and accountability. We provide 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 fastevolving field.

Education:

Bachelor's OR BTech OR B.Tech OR B.E OR Bachelor OR Masters OR MCA OR M.Tech

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