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Senior Manager Pharmacovigilance Aggregate Safety Reporting Oversight & Project Manager

Cambridge, Massachusetts

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Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

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Senior Manager Pharmacovigilance Aggregate Safety Reporting Oversight & Project Manager

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Job ID R0017019 Date posted 06/22/2020 Location Cambridge, Massachusetts

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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 Senior Manager of Pharmacovigilance Aggregate Safety Reporting Oversight in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager of Aggregate Safety Reporting Oversight working on the Pharmacovigilance team, you will be empowered to Innovate and Strategize.  

OBJECTIVE: 

Senior Manager, Aggregate Reporting is 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.

ACCOUNTABILITIES: 

  • Provides leadership to regional aggregate reporting team including training, mentoring, development and appraisals.
  • Assists in management of departmental budgets.
  • Ensures aggregate reporting processes and procedures are complete and compliant with current regulations globally.
  • Interacts and 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 and vendor team to deliver all 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.
  • Liaises with Regulatory Affairs to coordinate synchronization of aggregate reports.
  • Establishes and chairs document working groups comprised of authors and subject matter experts (SMEs) from the project or product teams, as necessary.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: 

  • Bachelor's degree required. Degree in scientific/medical field or advanced degree preferred.
  • Minimum 8 years pharmaceutical or health care related industry experience required; previous experience working in global environment preferred.
  • Minimum 5 years of experience in Pharmacovigilance with experience in preparation and submission of periodic aggregate safety reports.
  • Minimum 3 years of experience working with CROs, vendors, and relationship management preferred.
  • Minimum of 2 years of line management or matrix management required.
  • Demonstrated experience in people management and well-developed skills in team-building, motivating and developing people.
  • Expert knowledge of clinical trial and Pharmacovigilance methodologies including safety profile and risk/benefit analysis.
  • Excellent organization skills and ability to prioritize individual and team work loads.
  • Expert knowledge of Global regulatory requirements.
  • Experience in vendor management for outsourced activities.
  • Ability to work in a dynamic environment and manage competing priorities.
  • Understand safety data capture in clinical trials and post marketing settings.
  • Good written and verbal communication skills.
  • 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.
  • Ability to interpret, analyze and clearly present scientific and technical data
  • Scientific / medical writing (including word processing and data presentation packages (i.e. Word, Excel).
  • Ability to thrive in a global matrix environment.
  • Experience with aggregate analysis and writing PSUR's & NDA Periodic.  
  • Knowledge of case processing and aggregate reporting requirements.
  • Demonstrated proficiency with computer applications and understanding of safety data.
  • Knowledge of pharmaceutical business, including drug development and regulatory aspects.
  • Knowledge of US, EU and international regulatory/safety regulations and guidelines.
  • Fluency in oral and written English.

TRAVEL REQUIREMENTS:

· Some travel to global Takeda 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.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0017019

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