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 Sr. Project Manager Pharmacovigilance in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Sr. Project Manager Pharmacovigilance working on the PV Services team, you will be empowered to Create and Strategize. A typical day will include:
The Senior Project Manager works with the GPSE Chief of Staff, GPSE Leadership Team (GPSELT) members and other Senior Leaders across R&D in executing business and Safety related activities of the Global Pharmacovigilance function.
Key objectives include:
- Providing Project Management expertise for all business aspects of Global Patient Safety Evaluation (GPSE) business operations related to capacity planning, budgets, special initiatives and meeting logistics/facilitation.
- Support the Pharmacovigilance regulatory intelligence process
- Serving as a Project Manager for key Global Pharmacovigilance initiatives.
- Proactively managing activities related to the successful execution of the Takeda Safety Board.
- Partnering with GPSE colleagues to identify innovations and solutions for GPV process improvements to bring increasing value.
- Leads and/or facilitates GPSE projects/teams and GPSE initiatives and ensures all new projects have effective metrics and reporting to measure outcomes and impact on cost.
- Support the oversight and management of Pharmacovigilance related regulatory intelligence
- Work with teams to communicate key changes related to regulatory intelligence
- Lead the implementation and change management initiatives related to regulatory intelligence
- Support the internal review process of industry regulatory intellince
- Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the PV regulatory environment that may bear influence to Takeda
- Lead and facilitate PV regulatory intelligence gap analysis and implement solution to fill gaps
- Work closely and partner with several GPSE Subject Matter Experts to plan regulatory safety strategies and facilitate engagement with stakeholdersFacilitates the annual GPSE global meeting and follows up on actions/initiatives.
- Responsible for oversight and tracking of all GPSE initiatives and assists with global alignment of GPSE initiatives.
- Facilitates GPSE stakeholder communications as requested.
- Monitors and manages the project progress, project plan and resources identifying efficiencies and improvements while maintaining high quality standards. Reports on progress of project and issues/plans, proactively identifies obstacles, develops contingencies based on risk assesments and influences decision making.
- Identifies and resolves project progress/issues utilizing project tracking information.
- Under the guidance of the GPSE Chief of Staff, manages PV budgets (including support of the Drug Safety Officers), tracks functional resourcing, and reports on functional metrics when requested.
- Responsible for monthly functional reporting through reports/dashboards.
- Helps provide solutions for KPI support, external affairs guidnance and strategic communications with both external and internal stakeholders.
- Facilitate the system to track and monitor accurate records for the Safety Board/Safety Board Chair review process including gathering and distribution of materials, topic coordination/scheduling, generation of meeting agendas and meeting minutes/decisions that serve as a legal record of the Safety Board/Safety Board Chair Review discussions.
- Partners with other R&D functions to ensure Safety Board processes align with other functions and cross functional communication/training occurs as needed.
- Collaborate with the Global Safety Lead and/or other personnel to ensure that the safety issues are clearly addressed in Safety Board materials, teams are prepared for Safety Board discussions and actions are executed in clinical development plans or the post marketing setting.
- Responsible for setting and managing expectations of Development and Established Product teams, highlighting and resolving questions, and ensuring regular communications regarding Safety Board activities.
- Support/participate in continuous improvement of GPSEprocesses.
- Actively participate in internal and cross functional Task Forces by representing PV on local/global initiatives.
- Collect and communicate information regarding the global regulatory landscape as it relates to Pharmacovigilance.
- Establish expertise for evaluating global regulations that impact current processes/procedures and update accordingly to meet regulatory requirements.
- Mentor PV employees
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Minimum 6 years required in pharmaceutical drug development with experience in Pharmacovigilance, Clinical Research, Medical Affairs or Regulatory.
- Minimum 4 years experience leading complex pharmaceutical projects in pharmacovigilance or closely related field, a multi-disciplinary, global environment desired Bachelor s degree in science or business-related field
- 6 years of drug development experience in the area of pharmacovigilance, regulatory, medical affairs or clinical development
- Project planning experience wtihin the pharmaceutical industry
- 7 years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment
- Advanced degree, preferably in a science-related field
- Thorough knowledge of global drug development and Pharmacovigilance.
- In depth knowledge and comprehension of Pharmacovigilance regulations and ability to interpret multiple requirements into concise clear instructions
- Thorough knowledge of PV systems or and ability to quickly understand database and analytical tools
- Regulatory intelligence expreince
Knowledge and Skills:
- Demonstrated leadership skills managing matrix teams, influencing outcomes and key project decisions
- Proven ability to communicate and collaborate effectively with senior management
- Critical thinking and decision-making skills
- Ability to anticipate changes required in current business practices based on internal or external changes that impact GPV
- Ability to communicate effectively with external business partners
- Problem solving ability to think through problems and propose solutions to complex problems
- Ability to recognize problems before they occur, to appropriately raise issues to management, to bring an insightful approach to problem solving, and to communicate issues to stakeholders in a timely, mature, and professional manner
- Strategic thinking - ability to approach specific issues/problems with understanding of the larger context
- Communication skills strong ability to communicate, in writing or verbally, in an audience- and business-appropriate manner
- Strong organizational skills ability to organize information and data from various sources in an understandable and useful manner that is consistent with department standards
- Technically proficient in using Microsoft Word, Excel, and PowerPoint
- Management of multiple tasks of varied complexity simultaneously
- Presentation ability to present information in a clear and concise manner
- Negotiating skills
- Ability to work independently, or with a diverse group of individuals across various functional areas and organizations
- Ability to develop, articulate and establish processes which impact cross-functionally
- Demonstrate a high degree of self-awareness, self-motivation, initiative, and attention to detail
Periodic international travel to Takeda global sites may be required.
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.
No Phone Calls or Recruiters Please.