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The Head of The Center for Post Approval Safety Studies (CPASS) will have oversight of all regulatory required post-marketing safety studies, including EU Post-authorization safety studies (PASS), Regional Post-marketing surveillance studies, and other Post-marketing safety commitments/requirements. Maintains current knowledge and strategic oversight of assigned product portfolio and corresponding regulatory commitments which includes safety study commitments for products across multiple therapeutic areas. He/she is responsible for leading a team of Post-marketing safety Study Leads, a PMS Compliance Lead, understanding the regulatory requirements related to product approvals, worldwide product license renewals and submission/renewal strategies for assigned assets in development and marketed products. He/she is responsible for the development and internal approval of study protocols, monitoring of the study milestones and preparation of study related periodic and final reports for submission to worldwide regulatory agencies, with support from the Takeda study team and designated vendors when available.
Strategic guidance and ownership of the Post-marketing Safety Studies development and management is essential for the success of this role to support Takeda Marketed Products Development, and the project teams. Supervisory capabilities are needed to manage a team of Post-marketing Safety Study Leads.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
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:
USA - MA - Cambridge - Kendall Square - 500U.S. Base Salary Range:
$205,100.00 - $322,300.00The 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-term incentives. 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.
About Takeda Pharmaceuticals
Takeda is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines.
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