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Job Description

OBJECTIVE:

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.

Oversee operations performed by the PV BPO vendor including contract compliance, quality and timeliness of deliverables

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, BEHAVIOURAL COMPETENCIES AND SKILLS:

Bachelor’s required. Advanced degree in scientific/medical field preferred

Minimum 6 years pharmaceutical or health care related industry experience required

Minimum 5 years PV experience with 3 years experience working with CROs, vendors, and relationship management required

Global experience with CROs, vendors and relationship management 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

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. 

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

133,000.00 - 209,000.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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.

LocationsMassachusetts - Virtual

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes