Associate Director, Signal Management, CSPV

Daiichi Sankyo US-posted 3 months ago
$150,800 - $226,200/Yr
Full-time • Mid Level
Basking Ridge, NJ
5,001-10,000 employees
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Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a 'Global Pharma Innovator with Competitive Advantage in Oncology,' Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: This is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.

  • Lead the safety signal governance and develop or update associated policies, charter and procedures.
  • Provide total oversight on the processes relating to the conduct of signal detection via the appropriate tool(s).
  • Perform monitoring and tracking of the signal workflow to ensure compliance with procedural documents.
  • Assist the product safety teams in entering key signal information into the appropriate tool.
  • Advise teams on key milestones relating to the tracking of particular signal(s) to ensure compliance with global SOPs.
  • Lead the maintenance of signal tool and support tasks of change control, training material update, and end user support or process enhancement.
  • Determine the necessity and validity of change requests and perform user acceptance training when required.
  • Answer all queries relating to the signal detection tool and troubleshoot issues.
  • Develop and deliver ad-hoc and periodic trainings to build organizational capability on the entire signal management process.
  • Provide subject matter expertise to the GPTs on processes relating to signal detection, investigation, evaluation, and tracking.
  • Ensure compliance with applicable domestic and international regulations and ICH/GCP guidelines.
  • Provide oversight over compliance activities and foster a culture that seeks to enhance global regulatory compliance.
  • Develop quality systems and procedures for signaling activities to assure regulatory compliance.
  • Control and assure the quality of the material content of any documents sent to regulatory authorities.
  • Provide compliance metrics to management as needed.
  • Lead continuous improvement around development of new signal workflow/process, quality systems and tools.
  • Collaborate with cross-functional teams to ensure benefit-risk integration.
  • Represent the CSPV department as subject matter expert in cross-functional teams or committees.
  • Support audit and inspection readiness activities as a subject matter expert.
  • Maintain a state of inspection readiness and act as key representer of DS in inspections/audits.
  • Lead support for all corrective action/preventative action (CAPA) or process improvements for signal management.
  • Bachelor's Degree in Health care background or life science degree required; PharmD preferred; PhD preferred.
  • 5-7 years of relevant experience in pharmacovigilance within the pharmaceutical industry required.
  • At least 4 years of experience in PV signal detection required.
  • 3 years of experience collaborating on global project teams required.
  • Experience with safety databases and signal detection platforms required.
  • Experience in global PV inspection and/or audits required.
  • Strong knowledge of global PV regulations and signal detection methodologies required.
  • Exceptional working environment that values and rewards individual contributions.
  • Training, tools, and technology provided to excel.
  • Open communication and emphasis on results.
  • Spirit of personal accountability.
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