Director of Safety Operations

6 days ago

Bedford, Massachusetts, United States Lantheus Medical Imaging Inc Full time
Position Overview

Lantheus Medical Imaging Inc, a leading innovator in medical imaging solutions, is seeking a seasoned professional to fill the role of Director of Safety Operations. This position plays a critical part in ensuring the company's commitment to patient safety and regulatory compliance.

Responsibilities
  • Developmental Products:
    • Collaborate with clinical research teams and pharmacovigilance vendors to ensure timely and compliant processing of safety reports from all studies.
    • Provide technical support for data management, ensuring consistency, accuracy, and completeness in accordance with reporting requirements.
    • Oversee the efficient processing of safety reports, adhering to pharmacovigilance vendor safety management plans (SMP) and applicable regulations.
    • Develop and maintain dashboards documenting ongoing study status and provide regular updates to the pharmacovigilance team.
    • Offer guidance and support on safety-related aspects, including protocol development and study conduct.
    • Assist in preparing and updating Investigator Brochures (IB), IND Annual Reports, Development Safety Update Reports (DSURs), and other essential documents.
    • Review adverse event (AE) data from ongoing studies to identify common issues and summarize results to inform regulatory submissions or signal detection activities.
  • Business Partner Engagement:
    • Manage global business partner and vendor safety data exchange agreements (SDEAs) and pharmacovigilance contracts to ensure compliance with data exchange requirements.
    • Communicate with business partners and vendors regarding safety data processing and timely exchange as per SDEAs and vendor SMPs.
    • Distribute safety data, aggregate reports, and other necessary documents to business partners and facilitate reconciliation activities.
  • Mergers and Acquisitions:
    • Support the development of Lantheus' Global Pharmacovigilance department to address infrastructure needs resulting from product and/or company acquisitions.
    • Oversee migration and transition activities from due diligence until close-out, ensuring compliance with pharmacovigilance milestones.
    • Develop and execute required pharmacovigilance plans, including summaries of pharmacovigilance systems, project trackers, transition plans, data migration plans, and updated SMPs.
  • Other Responsibilities:
    • Support the Director of Pharmacovigilance in managing departmental activities, as needed.
    • Collaborate with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implement relevant standards into company practices.
    • Develop and maintain Global Pharmacovigilance-related documents, including Safety Management Plans, Standard Operating Procedures (SOPs), and Work Instructions.
    • Oversee deviation and Corrective Action Preventive Action (CAPA) activities related to late expedited report or aggregate report submissions, deviations from company procedures, business partner agreements, vendor SMPs, etc.

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