Associate Director, Global Patient Safety Signal Management and Innovation

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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 a Associate Director, Global Patient Safety Signal Management and Innovation in Cambridge, MA, where you ensure signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes. You will ensure that Takeda Signal Management processes and activities are compliant with EU regulations and EU regulatory authority and inspectors’ expectations. You will 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 GPSE stakeholders.

As part of the Patient Safety and Pharmacovigilance team, within the Risk Management and Education function, you will report to the Senior Director, Signal Management and represent the pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required.

• Conduct state-of-the-art research in the area of AI/ML.
• Design, drive, and promote novel advanced analytical tools building the next generation of safety capabilities by delivering value adding benefit/risk information.
• Acting as an interface between the Signal Management, Medical Safety, internal IT teams as well as vendor companies.
• Develop and integrate innovative solutions for AI/ML applications.
• Training and guiding users from Medical Safety to ensure compliance throughout the organization.
• Detection and Signal processing using Empirica, COGNOS, IVEA, Platypus, and any future applications.
• Work on current projects and innovative opportunities by providing subject matter expertise and technical support.
• Lead teams and guide team members to accomplish project’s goals.
• Perform program/project management and business development.
• Leads interactions with other relevant functional areas both within and outside of GPSE to ensure standards are maintained.
• Designs and delivers relevant training as appropriate.
• Provides mentorship and guidance for junior/new pharmacovigilance scientists and others as appropriate.
• Ensure compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure proper benefit-risk assessment and patient safety for company’s products.
• Ensure patient safety for company’s products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe.
• Timely completion of PV Assessment activities through product development, product maintenance and lifecycle management.
• Represent all activities related to pharmacovigilance, clinical safety, risk management and signal detection, and report back relevant information regarding status, issues, and/or challenges.
• Participate in training sessions, workshops, and/or conferences, and share knowledge with team members, as agreed.
• Ensure compliance management, as needed, with maintenance of SOPs within the scope of medical safety activities.
• Strategize and align with the GSLs in developing data analysis strategies and in generating outputs using suitable Pharmacovigilance database retrieval strategies.
• Create visualizations in the form of graphics and tables for regulatory reporting, internal safety updates, signal evaluations and other analysis purposes and product-specific matters.
• Generate the data including descriptive statistics, trend analysis, outliers, and correlations, and provide a preliminary assessment of relevant data, as well as reviews of prior data and relevant comparisons.
• Supports inspections and audits related to signal and risk-benefit commitments

• Graduate degree in health sciences, nursing, pharmacy, public health, epidemiology, or other relevant health-related field (MD, PhD, PharmD, NP, PA, pharmacy, or nursing degree) with at least 4 years of experience in clinical, pharmacological, or related fields of expertise OR Bachelor’s degree in health sciences, nursing, pharmacy, public health, epidemiology, or other relevant health-related field plus 10+ years of relevant experience in drug safety/pharmacovigilance, or related fields.
• Excellent communication and people skills and experience in mentoring others.
• Expertise in the following: Argus Safety Database, MedDRA, SharePoint, Microsoft Office, and Excel.
• Experience with Signal Detection and Pharmacovigilance databases i.e. Argus, Cognos, Empirica, etc.
• Good knowledge of reporting and visualization software and confirmed experience with relational databases and SQL.
• Demonstrated ability to work in a matrix environment and to influence key stakeholders as it relates to innovative safety science and pharmacovigilance.
• Demonstrated Project and Vendor Management skills.
• Strong analytical and problem-solving skills.
• Experience using Empirica for signal detection.
• Hands on experience developing, scaling, and implementing machine learning using relevant programming languages (such as Python), state of the art deep learning frameworks and big data tools.
• Excellent problem-solving skills and ability to dive into learning algorithms, model architecture, evaluation metrics, and field testing scenarios.
• Strong presentation, writing, and facilitation skills and will thrive in a highly dynamic environment, easily performing independent work, as well as leading effectively in team settings.
• Ability to review, analyze, interpret, and present complex data to a high standard.
• Excellent strategic decision-making and analytical skills - Strong leadership skills with excellent track record.
• Strong verbal, writing and organizational skills, including a good command of English.
• Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.
• In depth knowledge of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysis.
• Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities.
• Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment).
• Experience with the preparation of aggregate reports (DSUR, PSUR/PBRER, PADER).
• Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval.
• Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels.

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.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.