Associate Director, Risk Management応募後で応募 求人ID R0045146 掲載日 08/19/2021 Location:Boston, Massachusetts
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Risk Management, 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. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As an Associate Director, Risk Management, working on the Global Patient Safety Evaluation Pharmacovigilance (GPSE) 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 and additional Risk Minimization Measures and Materials. A typical day will include:
- Provides global support for specific therapeutic areas 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 safety risk management processes to maximize patient safety
- Ensures that GPSE safety risk management processes are continuously improved to reflect regulatory trends and guidelines, represent best practice, and are aligned with the global governance model
- Responsible for developing excellence in one of the following areas:
- Risk management Advisory Boards, coordinating topics and supporting meeting preparation
- Risk Minimisation and REMS evaluation methods
- Signal detection processes (linking with data-mining expertise in pharmacoepidemiology)
- Benefit-Risk Evaluation methods
- Responsible for excellence in risk management execution across therapeutic areas
- TA related responsibilities include:
- Provide leadership and expertise to ensure consistency of product risk management globally.
- Ensure risk mitigation, including REMS, risk communication measures and necessary compliance system improvements meet highest standards.
- Manage signal detection processes liaising with other functions to ensure best practice improvements are implemented where possible.
- Contribute to risk/benefit profile of products across therapeutic areas.
- Present risk management product proposals for Safety Board as needed
- Represent safety risk management and liability aspects as member of due diligence teams during acquisitions and contracts with partner companies
- Ensure regional implementation plans of global core risk management plan for a compound meets regional regulatory requirements
- Ensure regionally aligned principles and standard practices for risk management are consistent with global risk management policy and global benefit-risk assessment
- Lead regional strategy for implementation and evaluation of risk minimization activities
- Provide ongoing training for GPSE and related functions to ensure best drug safety risk management practice is implemented across the organization
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelors required. Advanced degree in life sciences preferred.
- Minimum 8 years of pharmaceutical/device industry experience with 3 years in international drug safety and risk management preferred.
- Pharmaceutical/device industry experience, with exposure to international drug safety and risk management
- Experience across multiple therapeutic areas preferred
- Strong track record of scientific and analytical thinking
- Experience presenting to technical and lay groups at public meetings is desirable
- Demonstrate integrity
- Motivate and empower others
- 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
- 10-30% domestic/international travel
This job posting excludes CO applicants
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 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.