Senior Director, Pharmacovigilance (PV) Operations

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Job Description

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 Director, Pharmacovigilance (PV) Operations in Cambridge, MA, where you will provide leadership and oversight to Global and Regional PV Operational Teams to ensure adverse event information is processed according to company timelines, performance indicators and quality standards. You will oversee and direct vendor(s) conducting PV operational activities for Takeda. Other PV operational activities includes regional case intake and global processing of Individual Case Safety Reports (ICSRs) monitoring global literature for ICSRs and other post marketing services.

As part of the Patient Safety & Pharmacovigilance (PSPV) team you will report to the Executive Director, PV Operations Oversight, and be responsible for ensuring operational strategy, contract compliance, quality and timeliness of deliverables, and continuous improvement efforts.

How you will contribute:                  

• Ensure standards for collection and processing of ICSRs which include alignment with GDPR requirements.
• Oversee development of global SOPs and policies to ensure compliance with regional PV regulatory requirements and to drive improvements in Takeda global PV processes.
• Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, key performance metrics, and  monitoring of performance and compliance, and training at a global level.
• Liaise with PV Systems team to ensure case processing SOPs and Tools contain guidance to allow for timely and accurate submissions to global health authorities, partners, etc.
• Lead PV relationships with PV vendor(s) and ensure compliance with Service Level Agreements (SLAs) and Pharmacovigilance Agreements (PVAs).
• Direct relationship with and output of vendor(s) in accordance with SLA:
  • Liaises with financial / project management for budget planning
  • Approve invoices and confirm accuracy of spend and bills
  • Lead case processing teams to assess / predict case volumes to ensure staffing planning at vendor
  • Direct planning for ad-hoc case processing related projects e.g. Legal cases
  • Lead and facilitate regular joint operating committee meetings to review / address issues if needed for:
    • Adherence to KPIs, OPIs and SLAs
    • Forecast demand
    • Issue escalations
    • Continuous improvement initiatives
    • Change management
  • Manage / review delivery against MSA terms
  • Monitor global KPIs and SLAs
  • Ensure quality of deliverables across teams
  • Represent voice of vendor to PV function
  • Provide guidance to delivery teams
  • Maintain operating procedures (describing operating rules with vendor)
  • Lead change management and ongoing training
  • Establish and manage vendor oversight procedures

• Partner with PSPV Compliance and QA teams to establish and manage vendor quality agreement procedures.
• Drive preparedness for regulatory authority inspection and internal audits for PV operational activities for Takeda; participate in audits/inspections as Subject Matter Expert (SME) and mentor colleagues/direct reports in audit/inspection preparedness and participation.

Minimum Requirements/Qualifications:

• Bachelors required.  Advance degree preferred.
• A minimum of 10 years of pharmaceutical or health care related industry experience required.
• Minimum 6 years PV experience with 3 years experience working with CROs, vendors, and relationship management preferred.
• Must have significant PV experience including experience working with CROs, vendors, and relationship management.
• Must have experience in Global PV inspections which include serving as an SME with direct contact with inspectors.
• Must have experience in preparing written responses from inspection findings, completing CAPA and implementing efficacy checks.
• Good cross cultural and cross functional understanding and experience, and ability to liaise with relevant teams/departments such as medical information, regulatory, affiliate relations
• Experience in people management and well developed skills in teambuilding, motivating, empowering and developing people.
• Demonstrated skills in negotiation and consensus decision making.
• Demonstrated effectiveness in external partner relationship management.
• Understanding of medical/scientific terminology.
• Knowledge of PV regulations for global pre- and post-market products.
• Good analytical/judgment capabilities to understand/analyze/synthesize and communicate successfully as well as key decision making capability.
• 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.
• Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills.

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 "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

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EEO Statement

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.

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