PV Risk Management Scientist/Associate Director

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Job Description

Are you looking for a patient-focused, innovative-driven company that will inspire you and empower you to shine? Join us as a PV Risk Management Scientist/Associate Director.  At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a value-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do.

As an Associate Director/ PV Risk Management Scientist, being part of our Risk Management and Benefit risk center of excellence, you will be empowered to work cross-functionally with colleagues to establish and manage the processes for Risk Management, benefit risk, RMPs, additional Risk Minimization Measures and REMS programs and Benefit Risk deliverables.

How you will contribute:

• Provides guidance and subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide

• Provide guidance and subject matter expertise on the structured benefit risk assessment framework and the development of the benefit risk assessment document

• Engages with partner global functions (e.g. Clinical Science, Med Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety

• Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning.

• Support the development of risk management plans (RMPs) in modular format, review RMPs) and ensure alignment with Good Pharmacovigilance Practices and other applicable regulations

• Develop and review risk minimization documents such as additional risk minimization measures (aRMMs) and Risk Evaluation and Mitigation Strategy (REMS)

• Provide subject matter expertise and thoughtful contributions to qualitative and quantitative structured benefit risk assessments

• Provide guidance on incorporation of the patient’s perspective into benefit-risk activities (e.g. patient preference studies)

• Collaborate with Safety Leads, Clinical Leads, PV scientists and Clinical Research Scientists, and others cross-functional teams on benefit risk assessment strategy

• Develop and provide recommendations for appropriate risk management interventions such as direct healthcare professional communications, educational materials, controlled access program

• Provide guidance regarding tracking risk management commitments including utilization of a tracking platform and system improvement assessment

• Monitor and report risk management metrics to ensure compliance

• Provide centralized support, training, and leadership for safety and cross-functional members who work on risk management plans and risk minimization activities.

• Support inspections and audit activities with regards to risk management processes

• Perform other duties as defined in standard operation procedures or requested by supervisor.

Minimum Requirements/Qualifications:

• Associate Director: PhD/PharmD/DO/MD + 3 years; OR Masters + 5 years; OR Bachelors + 7 years

• Minimum 2 years in PV/safety OR clinical development preferred

• Minimum 3 years of pharmaceutical industry/drug development experience

• Pharmaceutical industry experience, with exposure to PV risk management, additional risk minimization measures, and/or REMS programs preferred

• Strong track record of scientific and analytical thinking

• Experience presenting to technical and lay groups at public meetings is desirable

• Demonstrate integrity and work productively in a high-pressure environment

• Good analytical/judgment capabilities to understand/analyze/synthesize, and communicate

• Project Management abilities

• Ability to identify and understand proactively the interactions necessary for achieving business goals and objectives

• Able to manage both time and priority constraints and to manage multiple priorities simultaneously

• Attention to detail, computer literacy, knowledge of safety databases

• Take initiative and autonomous action

• Proven ability to work in an international environment and with cross-functional teams, with good interpersonal skills/assertiveness / team spirit/coaching skills

This position is currently classified as “hybrid” in accordance with 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:

Boston, MA

U.S. Base Salary Range:

$153,600.00 - $241,340.00

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

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