Sr. Manager PV Processes

Takeda Pharmaceutical Company Ltd Cambridge , MA 02138

Posted 2 months ago

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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.

#LI-KL1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


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Sr. Manager PV Processes

Takeda Pharmaceutical Company Ltd