Associate Director, Signal Management Process Excellence

Takeda Pharmaceutical Company - Lansing, MI

Full-time - Senior

Remote - Lansing, MI

Chemical Manufacturing

About the position

The Associate Director, Signal Management Process Excellence at Takeda 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, acting as a subject matter expert in signal detection and management.

Responsibilities

• 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 support audits and inspections as a subject matter expert.
• 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 guidelines for benefit-risk assessment and patient safety.
• Conduct project activities for designated processes.

Requirements

• 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, signal detection, and risk/benefit analysis.
• Strong critical, strategic thinking, and decision-making skills.
• Ability to review, analyze, interpret, and present complex data effectively.
• Experience working in a global pharmacovigilance organization and adapting to change.
• Collaborative skills in a cross-functional, global environment.
• Excellent document creation, communication, and presentation skills.
• Good level of computer literacy and project management skills.
• Proven track record in process improvement and implementing process excellence initiatives.

Benefits

• Medical, dental, and vision insurance
• 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 accrual
• Paid vacation accrual up to 120 hours per year