Associate Director Risk Management (Medical Safety)

Takeda Pharmaceuticals - Cambridge, MA3.8

Full-timeEstimated: $100,000 - $130,000 a year
SkillsBenefits
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Job Description
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Associate Director, Risk Management in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Associate Director Risk Management, working on the Pharmacovigilance team, you will be empowered to Innovate and Strategize. A typical day will include:

POSITION OBJECTIVES:
Provides subject matter expertise in risk management / risk evaluation and mitigation strategies REMS, in the assessment of product benefit-risk across therapeutic areas within Takeda Global Patient Safety and Evaluation (GPSE)
Advise on the strategy, preparation and authoring of RMPs for products across therapeutic areas
Advise teams on adequate responses to health authority queries relating to product RMP, REMS and benefit-risk assessment
As applicable, lead the development of additional risk minimization tools with scientifically balanced content grounded in risk minimization principles
Oversee implementation of risk minimization activities by local operating companies and ensure local risk management activities are aligned with the core risk management strategy
Oversee and maintain collaborative working environment with vendors, on RMP/REMS activities
Ensures product team compliance with GPSE risk management and benefit-risk processes, as well as current RMP/REMS regulatory trends/guidelines and best practices

POSITION ACCOUNTABILITIES:
Excellence in Risk Management Strategy and Benefit/Risk strategy
Provide global strategy to ensure that product risk management strategies are consistent worldwide
Accountable for risk management best practices and principles in defining a product’s risk management strategy
Oversight of collaborative working with vendors, on RMP/REMS activities

Risk Management and B/R Processes:
Ensure regionally aligned principles and standard practices for risk management are consistent with global risk management policy and global benefit-risk assessment
Advise teams on the maintenance and authorship of the Core-RMP, EU-RMP, REMS and other RMP including those for first or supplementary MAA and NDA submissions

Culture/Environment::
Promotes a culture of risk management and benefit-risk excellence
Collaborate with GPSE sub-functions and with partner vendors to deliver RMP / REMS deliverables

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Advanced degree in life sciences
Minimum 10 years of pharmaceutical/device industry experience with at least 5 years in pharmacovigilance and risk management
Experience in liaising with regulatory agencies, professional groups and/or academic centers
Experience with developing risk management plan or risk evaluation and mitigation strategy, risk minimization tools, authoring RMP and REMS
Experience with the application of a benefit-risk assessment framework
Experience with assessing the effectiveness of additional risk minimization measures or activities, and the evaluation of REMS methods
Competencies and Skills

Strong track record of scientific and analytical thinking
Integrity and leadership
Ability to relate well to people and to motivate and empower others
Capacity to take initiative and work productively in a high-pressure environment Communication with clarity and brevity
Project management abilities and insights required to work productively in a global company and across multiple functions
Strong knowledge of business area and understand the proactive interactions necessary to achieve business goals and objectives
Capacity to manage time and priority constraints as well as manage multiple priorities simultaneously
Attention to detail
Computer literacy, including knowledge of safety database
Ability to lead meetings and teleconferences, both internally in Takeda as well as externally to technical and lay groups and public meetings

TRAVEL REQUIREMENTS:
Some domestic and international travel may be required on an infrequent basis.

WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan

l Tuition reimbursement

l Company match of charitable contributions

l Health & Wellness programs including onsite flu shots and health screenings

l Generous time off for vacation and the option to purchase additional vacation days

l Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified

applicants with criminal histories in accordance with applicable laws. For more information, visit

http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

Locations

Boston, MA

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Locations
Cambridge, MA

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job ID R0012096