Associate Director, Signal Management Process Excellence

Takeda Pharmaceutical Company - Trenton, NJ

Full-time - Senior

Trenton, NJ

Chemical Manufacturing

About the position

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), identifying areas for continuous improvement, and implementing 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 during audits and inspections.

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 act as a subject matter expert during audits.

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 and pharmacovigilance regulations.
• Experience in signal detection and risk/benefit analysis.
• Strong critical, strategic thinking, and decision-making skills.
• Ability to review, analyze, interpret, and present complex data.

Nice-to-haves

• Experience with regulatory compliance in signal management processes.
• Familiarity with ICH/GCP guidelines.
• Previous experience in training or educational roles within the pharmaceutical industry.

Benefits

• Health insurance
• 401k plan
• Paid time off
• Professional development opportunities