Associate Director, PV Sciences, Global Medical Safety Oncology

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Job Description

OBJECTIVE:

Principal responsibilities include:

• Supports the Global Safety Lead (GSL) for assigned oncology pharmaceutical / biological / drug-device combined products.
• Responsible for safety surveillance, signal detection and risk management activities.
• Supports cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
• Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products.
• Represent pharmacovigilance, both regionally and globally, as an authoritative and knowledgeable member of Global Program Teams (GPTs) and subteams, commensurate with position’s seniority/experience.
• Coordinates all aspects of signal detection and safety surveillance and review activities, in collaboration with the GSL, for assigned product(s).

ACCOUNTABILITIES:

• Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature.
• Facilitate ongoing safety surveillance for assigned products, assisting with or leading data collection and assessment for the GPSE Safety Team (GST) and Safety Management Team (SMT).
• Coordinate and perform signal identification, evaluation and management activities for assigned products, ensuring communication of all safety information that may impact the benefit-risk profile of assigned products to senior management.
• Assist with or lead authoring of safety evaluations, defining scope and methodology and providing background information for aggregate safety reports, conducting preliminary safety analyses, and preparing ad hoc reports including Health Hazard Evaluations, Signal Evaluation Reports, and Health Authority responses.
• Partner with cross-functional colleagues of the SMT and contribute to safety-related deliverables associated with new drug applications, benefit-risk assessments and activities related to risk minimization including RMPs.
• Liaise with colleagues in relevant functional areas within and outside of PSPV to gather and provide input for appropriate sections of critical documents (e.g., protocols and amendments, ICFs, IBs, core data sheets, IMPDs, CSRs, INDs, NDAs, BLAs, and CTAs).
• Liaise with other relevant functional areas both within and outside of global PV to best ensure the most efficient and timely attainment of compliant and patient focused safety data.
• Represent PSPV in cross-functional teams or committees and external environments at a global and regional level as required, with the advanced communication skills this requires.
• Assist with or lead the preparation and presentation of identified and potential patient safety risks and SMT recommendations on safety issues to cross-functional decision-making bodies such as the Takeda Safety Board. Where acting as the GSL can expect to lead presentations to Safety Board, with the detailed preparatory work this implies and, where ad hoc issues arise, manage the short timelines that can ensue.
• Build and maintain in-depth knowledge and understanding of designated products/studies, and close knowledge of protocols to effectively respond to safety issues.
• Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents.
• Demonstrate outstanding knowledge of local and global health authority requirements.
• Support PSPV in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations.
• Train and mentor newly hired peers and incumbent PV Scientists.
• Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and foster a community of continual learning.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent qualification; advanced degree in scientific or medical field preferred.
• Minimum 10 years of relevant biotech/pharmaceutical experience.
• Excellent working understanding of safety database configuration and adverse event coding to direct advanced searches.
• In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety data analysis and benefit-risk assessment, and understanding of drug development.

TRAVEL REQUIREMENTS:

• Some travel to global Takeda sites may be required.

ADDITIONAL US SPECIFIC INFORMATION:

• Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent qualification; advanced degree in scientific or medical field preferred.
• More than 10 years of relevant biotech/pharmaceutical experience.

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:

Boston, MA

U.S. Base Salary Range:

$153,600.00 - $241,340.00

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-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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.