Director, Pharmacovigilance Risk Management
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Director, Pharmacovigilance Risk ManagementApply Now
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 PV Director, Risk Management in our Cambridge office.
- Provides global strategic leadership and subject matter expertise in risk management / risk evaluation and mitigation strategies, 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
- Excellence in Risk Management Strategy and Benefit/Risk
- Provide global strategic leadership 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
- 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
- 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, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Advanced degree in life sciences or MD required
- Minimum 10 years of pharmaceutical/device industry experience with at least 5 years in pharmacovigilance and risk management
- Prior leadership and management experience (preferred)
- 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
- 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
- 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
- Tuition reimbursement
- Company match of charitable contributions
- 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
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
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Job ID R0021468