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Sr. Manager PV Processes

Cambridge, Massachusetts

Overview

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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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

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

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

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

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • 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 2018.

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Sr. Manager PV Processes

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Job ID R0013332 Date posted 10/14/2019 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 Sr. Manager PV Processes in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Sr. Manager PV Processes working on the PV Services team, you will be empowered to Create and Strategize. A typical day will include: 

OBJECTIVE:  .

  • Oversee operations performed by the PV BPO vendor including contract compliance, quality and timeliness of deliverables.
  • Serve as a primary liaison and point of contact for vendor operations and vendor oversight, including vendors performing case management, case intake (i.e., Call Centers), scientific literature review, etc.
  • Serve as the primary liaison and point of contact for vendor operations including the PV BPO vendor and/or vendors performing case management, case intake, literature review; call centers
  • Provide Subject Matter expertise (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, legal case processing, vendor oversight, etc.

ACCOUNTABILITIES: 

  • Provide leadership and oversight on case management for the Global PV Operations Team to ensure adverse event information is processed according to company timelines and quality standards
  • Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to global Health Authorities, alliance partners, local operating companies (LOCs) including SUSAR and SAE communication to ECs and investigators as applicable
  • In partnership with the Global Standards and Compliance team, direct and manage communication with alliance partners, LOCs and CROs regarding the evaluation and processing of ICSRs
  • In partnership with the Global Standards and Compliance team, lead and direct the review and approval of alliance partner safety data exchange agreements for the inclusion of appropriate safety reporting requirements
  • Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, metrics, and  monitoring of performance and compliance, and training at a global level
  • Oversee and direct reconciliation processes for case exchange with LOCs and alliance partners
  • Lead PV relationship with PV BPO vendor and/or vendors performing case management to ensure compliance with SLAs
  • Support LOCs in PV tasks responding to queries and requests regarding case handling
  • Interface with commercial quality for product complaints; assist in obtaining follow-up when necessary for adverse events, product quality complaints or other safely information
  • Direct relationship with and output of BPO partner(s) in accordance with SLA
    • Liaises with financial / project management for budget planning
    • Approve actual invoices and confirm accuracy of spend and bills
    • Coordinate clinical and project management case processing teams to assess / predict case volumes to ensure staffing planning at vendor
    • Lead planning for ad-hoc case processing related projects e.g. Legal cases or AE/SAEs generated through marketing surveys
    • Lead and facilitate regular joint operating committee meetings to review / address issues if needed for:
      • Adherence to KPIs 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 manual (describing operating rules with vendor)
    • Lead change management and ongoing training
  • Establish and manage vendor oversight procedures
  • Partner with QA to establish and manage BPO vendor quality agreement procedures include vendors performing case management/intake activities or literature review and surveillance

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Bachelor’s required.  Advanced degree in scientific/medical field preferred.
  • Good cross cultural understanding and experience
  • Experience in people management and well developed skills in teambuilding, motivating and developing people.
  • Demonstrated skills in negotiation and consensus decision making
  • Critical thinking and analytical skills and ability to make key decisions
  • Demonstrated effectiveness in external partner relationship management
  • Understanding of medical/scientific terminology
  • Good knowledge of PV regulations for the global pre-and post-market, i.e. FDA, EMA, ICH GVP
  • Experience with safety databases, including MedDRA and WHO Drug
  • Excellent written/oral communication skills
  • Accuracy and attention to detail
  • Flexible mindset
  • Team worker with collaborative approach
  • Ability to prioritize under pressure
  • Well-developed organizational skills

LICENSES/CERTIFICATIONS:

RN or Pharmacist preferred

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.

No Phone Calls or Recruiters Please.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0013332

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