Associate Director, Signal Management Process Excellence

Takeda Pharmaceutical

10+ years

149,100.00 - 234,300.00

Remote

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?

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Associate Director, Signal Management Process Excellence

Job Description

Associate Director, Signal Management Process Excellence

Key Responsibilities

Process Excellence and Compliance

Collaboration and Training

Leadership and Auditing

Strategic Contributions

Minimum Requirements

Education and Experience

Skills and Knowledge

Preferred Qualifications

Work Environment and Benefits

Why Join Takeda?

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