Takeda Pharmaceutical Company-posted about 1 year ago
Full-time • Senior
Remote • Juneau, AK
Chemical Manufacturing

The Associate Director, Signal Management Process Excellence at Takeda Pharmaceuticals is responsible for overseeing signal management processes to ensure compliance with regulatory requirements. This role involves monitoring key performance indicators (KPIs), conducting reviews for continuous improvement, and developing strategies to enhance the efficiency and quality of signal management activities. The position requires collaboration with cross-functional teams and participation in inspection readiness activities, serving as a subject matter expert in signal detection and management.

  • Oversee signal management processes to ensure compliance with regulatory requirements.
  • Monitor and document signal management KPIs and metrics.
  • Conduct reviews of signal management processes to identify areas for continuous improvement.
  • Develop and implement process excellence strategies to enhance efficiency and quality.
  • Collaborate with cross-functional teams to develop resources and training materials.
  • Participate in inspection readiness activities and serve as a subject matter expert during audits.
  • Act as an interface between Signal Management, Medical Safety, and vendor companies to identify process enhancement opportunities.
  • Keep up to date with applicable regulations and ICH/GCP guidelines.
  • Conduct project activities for designated processes.
  • Health care background or life science degree/Bachelors required; degree in life sciences preferred.
  • At least 10 years of relevant experience in pharmacovigilance within the pharmaceutical industry.
  • In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, and signal detection.
  • Critical thinking and decision-making skills.
  • Ability to analyze, interpret, and present complex data.
  • Experience working in a global pharmacovigilance organization.
  • Excellent document creation, communication, and presentation skills.
  • Strong organization and project management skills with the ability to prioritize.
  • Proven track record in process improvement and implementing process excellence initiatives.
  • Experience in training sessions, workshops, and conferences.
  • Ability to work collaboratively in a cross-functional, global environment.
  • Medical, dental, and vision insurance coverage.
  • 401(k) plan with company match.
  • Short-term and long-term disability coverage.
  • Basic life insurance.
  • Tuition reimbursement program.
  • Paid volunteer time off.
  • Company holidays.
  • Well-being benefits.
  • Sick time and paid vacation accrual.
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