15 days old

Senior Manager, Pharmacovigilance Processes

Takeda Development Center Americas, Inc.
Boston, MA 02109
  • Job Code
    R0069425
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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, Pharmacovigilance Processes, in our Cambridge, Massachusetts office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Senior Manager, Pharmacovigilance Processes, working on the Global Patient Safety and Evaluations team, you will be empowered to 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. A typical day will include:

POSITION OBJECTIVES:

  • 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. RN or Pharmacist preferred.
  • Minimum 6 years pharmaceutical or health care related industry experience required; 5 of those years required to be in PV experience with 3 years experience working with CROs, vendors, and relationship management required
  • 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
  • Global experience with CROs, vendors and relationship management preferred

Base Salary Range: $ 130,000 to $ 186,000 based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. 8-5-101 et seq.

WHAT TAKEDA CAN OFFER YOU:

Empowering Our People to Shine

Learn more at takedajobs.com

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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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.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2022-06-17 Expires: 2022-07-16
Sponsored by:
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Sponsored by:
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Senior Manager, Pharmacovigilance Processes

Takeda Development Center Americas, Inc.
Boston, MA 02109

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