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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as an Associate Director, Signal Management Process Excellence in Cambridge, MA, where you will oversee the signal management processes to ensure that signal management activities are performed according to regulatory requirements. You will monitor and document signal-management related Key Performance Indicators (KPIs) and metrics and support requests regarding information related to signal management KPIs.This role will conduct review of signal management processes to identify areas for continuous improvement along with develop and implement process excellence strategies to enhance the efficiency and quality of signal management activities.

As part of the Signal Management and Innovation (SMI) team, you will report to the Senior Director, Head, Signal Management and Innovation (SMI). You will review and support updates to signal management controlled documents and training materials to stay up to date with process updates, updated regulatory requirements, and process improvements associated with signal management processes. You will collaborate with cross-functional teams e.g., PSPV Training, PSPV Risk Management & Education, and Document Learning Excellence (DLE) to develop resources and training materials for interactive live and online trainings on signal management processes and intersections with supporting functions, and safety and signal management related topics. Lastly, you will participate in inspection readiness activities, including review of archived documentation in support of Signal Management processes, and as a signal detection and management subject matter expert (SME) during audits and inspections.

How you will contribute:

• Act as an interface between the Signal Management, Medical Safety, as well as vendor companies on matters of Signal Management to identify areas of opportunities for process enhancements and efficiencies. 

• Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal PSPV stakeholders.

• Keep up to date with applicable regulations and ICH/GCP guidelines to ensure proper benefit-risk assessment and patient safety for company’s products.

• Represent all activities related to pharmacovigilance, clinical safety, risk management and signal detection, and report relevant information regarding status, issues, and/or challenges.

• Participate in training sessions, workshops, and/or conferences, and share knowledge with team members, as agreed.

• Conduct project activities for designated processes.

• Any other tasks assigned by manager to assist in related departmental activities.

Minimum Requirements/Qualifications:

• Health care background or life science degree/Bachelors required; degree in life sciences preferred

• Experience in the pharmaceutical industry with at least 10 years of relevant experience in pharmacovigilance

• In depth knowledge and experience of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysis

• Critical, strategic thinking and decision-making skills

• Ability to review, analyze, interpret and present complex data to a high standard

• Global player in a PV organization with the ability to adapt to change

• Ability to work collaboratively in a cross-functional, global environment

• Excellent document creation, communication, and presentation skills

• Good level of computer literacy

• Excellent organization and project management skills with ability to prioritize

• Proven track record in process improvement and implementing process excellence initiatives

More About Us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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