at Takeda Pharmaceuticals in Montpelier, Vermont, United States
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Senior Manager, Aggregate Safety Reporting Oversight, on our Global Patient Safety Lifecyle Management and Analytics (GPS-LCMA) Team where you will be empowered to be responsible for the development, implementation and maintenance of robust procedures for the planning, preparation and submission of high-quality aggregate safety reports, in compliance with requisite global and local regulations and requirements. This is a virtual/remote role.
How you will contribute:
+ Provides leadership to regional aggregate reporting team including training, mentoring, development, and appraisals
+ Assistsinmanagement of departmental budgets
+ Ensures aggregate reporting processes and procedures are complete and compliant with current regulations globally
+ Interactsand communicates effectively internally and cross-functionally in a highly matrix environment.
+ Responsible for the implementation and management of effective structure, procedures, and tools to ensure aggregate report and other functional deliverables are completed with high quality
+ Responsible for global leadership and strategic oversight of aggregate safety reports for investigational and marketed products
+ Collaborates with Global Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs, Finance, Safety Statistics, etc.) contributing to aggregate safety reports
+ Manages distribution of assignments and prioritization of tasks within the Pharmacovigilance operations aggregate reporting team
+ Manages resource planning and ensures adequate support from internal team andvendorteamtodeliverall scheduled safety reports.
+ Manages commitments with license partners to ensure both meet aggregate reporting requirements as per the PV Agreement between companies.
+ Provides strategic and financial oversight of Vendor and manages both quality and compliance of assignments, including training and mentoring when appropriate
+ Oversee functional specifications of any data requirements for aggregate deliverables from the Global safety database and analytics team
+ Responsible for maintaining compliance metrics and contributes to implementation of Corrective Action and Preventive Action (CAPA) for non- compliance findings
+ Support continuous improvement/quality system initiatives; Assist in preparation and support of audits and inspections
+ LiaiseswithRegulatory Affairs to coordinate synchronization of aggregate reports
+ Establishes and chairs document working groups comprised of authors and subjectmatterexperts(SMEs)fromtheprojectorproductteams,asnecessary
+ Bachelorsrequired.Degreeinscientific/medicalfieldoradvanceddegree preferred
+ Minimum 5 years of experience in pharmacovigilance with high level of exposure in preparation and submission of periodic aggregate safety reports and risk management plans
+ Demonstrated experience in people management and well-developed skills in teambuilding, motivating and developing people.
+ Expert knowledge of clinical trial and Pharmacovigilance methodologies including safety profile and risk/benefit analysis
+ Expert knowledge of Global regulatory requirements
+ Understand safety data capture in clinical trials and post marketing settings
+ Ability to work under strict deadlines and changing priorities with minimal supervision
+ Excellent negotiation, conflict resolution, decision making, problem solving and critical thinking skills
+ Experience with and demonstrated success in working on cross-functional diverse teams required
+ Scientific / medical writing (including word processing and data presentation packages (i.e., Word, Excel)
+ Experience with aggregate analysis and writing PSUR’s & NOA Periodic.
+ Knowledgeofcaseprocessingand aggregate reporting requirements.
+ Demonstratedproficiencywithcomputer applications and understanding of safety data.
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: $130,000 to $186,000, 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.
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.
Massachusetts – Virtual