Instagram
youtube
Facebook

Associate Director, Signal Management Process Excellence

10+ years
149,100.00 - 234,300.00
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director, Signal Management Process Excellence

Location: Cambridge, MA (Remote)
Company: Takeda Pharmaceuticals

This role is a leadership position within Takeda’s Signal Management and Innovation (SMI) team, focusing on enhancing signal management processes, maintaining compliance with regulatory requirements, and driving process excellence. It offers a chance to collaborate globally, lead process improvements, and ensure patient safety through efficient pharmacovigilance practices.


Key Responsibilities

Process Excellence and Compliance

  • Oversee and refine signal management processes, ensuring alignment with regulatory requirements (e.g., ICH/GCP).
  • Monitor Key Performance Indicators (KPIs) and metrics for signal management activities, providing data-driven insights for process improvements.
  • Lead the development and implementation of strategies to enhance efficiency and quality in signal detection and management.

Collaboration and Training

  • Act as a liaison between Signal Management, Medical Safety, and vendor teams to identify opportunities for process enhancement.
  • Collaborate with PSPV Training, Risk Management & Education, and other teams to develop interactive training materials.
  • Conduct training sessions and knowledge-sharing workshops on pharmacovigilance and signal management.

Leadership and Auditing

  • Lead inspection readiness activities, serving as a Subject Matter Expert (SME) during audits and inspections.
  • Ensure proper documentation and compliance with established processes.
  • Represent Takeda’s pharmacovigilance and safety standards in internal and external forums.

Strategic Contributions

  • Stay current on evolving regulations to anticipate changes in benefit-risk assessment and patient safety.
  • Analyze and present complex data to inform strategic decision-making.
  • Drive continuous improvement initiatives within the signal management function.

Minimum Requirements

Education and Experience

  • Bachelor's degree in life sciences or a healthcare-related field (advanced degree preferred).
  • 10+ years of experience in the pharmaceutical industry, with expertise in pharmacovigilance, signal detection, and risk-benefit analysis.

Skills and Knowledge

  • Deep understanding of clinical trial methodologies and global pharmacovigilance regulations.
  • Proven ability to lead process improvement initiatives and implement process excellence strategies.
  • Strong organizational, project management, and analytical skills.
  • Proficiency in creating documentation and presenting complex data effectively.
  • Ability to thrive in a collaborative, cross-functional, and global environment.

Preferred Qualifications

  • Experience in global pharmacovigilance operations and working with international regulatory bodies.
  • Strong background in computer literacy and familiarity with signal management tools.

Work Environment and Benefits

  • Position Type: Remote, with 5-30% travel as needed for meetings, audits, or inspections.
  • Compensation: Base salary range: $149,100 - $234,300, dependent on qualifications and location.
  • Eligible for short-term and long-term incentives, medical and dental benefits, 401(k) with company match, tuition reimbursement, and more.

Why Join Takeda?

At Takeda, you’ll be part of a forward-thinking, innovative R&D organization focused on transforming patient care. As a Global Top Employer, Takeda fosters a collaborative and inclusive work environment that values growth, innovation, and excellence.

If you're passionate about advancing pharmacovigilance and making a global impact on patient safety, this is your opportunity to contribute to life-changing therapies at Takeda.

Would you like help preparing for this role?