Senior Manager OR Associate Director, PV Risk Management and REMS

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Job Description

About the role:

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, PV Risk Management and REMS, OR Associate Director, PV Risk Management and REMS virtually or in our Cambridge, Massachusetts office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-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 a Senior Manager or Associate Director, PV Risk Management and REMS, working on the GPSE/Risk Management team, you will be empowered to work with colleagues within Risk Management and Organ Toxicity Centre of Excellence (RiMOT CoE) to establish and manage the processes for Risk Management, additional Risk Minimization Measures and Materials, and REMS programs.

How you will contribute:

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• 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
• 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 (aRMM) and Risk Evaluation and Mitigation Strategy (REMS)
• Provide subject matter expertise and thoughtful contributions to qualitative and quantitative structured benefit risk assessments
• Develop and present recommendation 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 minimizations activities.
• Support inspections and audits 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
• Senior Manager: Phd/PharmD/DO/MD + 2 years; OR Masters + 4 years; OR Bachelors + 6 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
• Work productively in a high pressure environment
• Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
• Project Management abilities
• Strong knowledge of business area and interactions with strong regulatory environment and 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 details, computer literacy, knowledge of safety database
• Take initiative and autonomous action
• Able to lead teleconferences and meetings
• Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

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" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $143,000 to $205,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

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