Posted to MedZilla on 8/16/2018


Takeda Pharmaceuticals

US-MA, Senior Manager, Pharmacovigilance Quality Assurance R0000100-MZ


 
 

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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 Senior Manager, Pharmacovigilance Quality Assurance in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager working on the Pharmacovigilance Quality Assurance team, you will be empowered to ensure Pharmacovigilance compliance, and a typical day will include:

POSITION OBJECTIVES:

  • Act as Research and Development Pharmacovigilance Quality Assurance (R&D PVQA) function in the respective region. Ensure that system audits are conducted, communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are appropriate and implemented.
  • Support Management to serve as a strategic Good Pharmacovigilance Practice (GVP) resource to Takeda for its drug development activities, and supports the preparation, conduct, and development of responses to health authority inspections of Takeda s development activities.
  • Collaborates with R&D Quality, Global Quality, R&D operational functions, and suppliers of outsourced services to ensure that Pharmacovigilance activities are conducted in compliance with GVP regulations, the International Conference on Harmonization (ICH) and Takeda requirements

POSITION ACCOUNTABILITIES:

  • Implement and refine processes to ensure that Takeda maintains oversight of the quality of its pharmacovigilance activities in compliance with applicable regulatory requirements.
  • In collaboration with R&D Pharmacovigilance Quality Assurance support the development of tactical and strategic audit plans.
  • Plan and conduct Pharmacovigilance system audits in support of global PV activity for post marketed and clinical development products, including TDC, TPNA and marketing licensees to assure compliance with the Code of Federal Regulations, EU Directive, local regulations, ICH and Takeda policies and procedures.
  • Facilitate timely PV audit responses and evaluate proposed corrective actions, and/or preventative actions, including effectiveness checks for compliance with applicable regulations, guidelines, and Takeda policies.
  • Facilitate risk mitigation and escalate inadequate audit responses to management.
  • Provide vendor management oversight to consultant auditors by facilitating the end-to-end audit process.
  • Provide support, guidance and training to external consultant auditors on the specific PVQA audit processes, tools and systems used to conduct the audit

  • Conduct a peer review of audit plans, reports and audit observations and communicate with consultant auditors about clarifications of observations, ratings and objective evidence.
  • Contribute to the development of process improvement initiatives that enhance regulatory compliance and PV QA efficiencies.
  • Support PV regulatory inspections
  • Support the ongoing development and operational success of the PV Quality Assurance function.
  • Provide appropriate risk analysis for key stakeholders to make critical decisions.
  • Ensure reports and appropriate (corrective and/or preventive) actions are developed and completed within timelines mandated in internal procedures.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor s required; Advanced degree preferred
  • Minimum 6 years of applicable pharmaceutical drug development/clinical experience
  • Minimum 3 years of PV-related Quality Assurance and Auditing experience strongly preferred.
  • In-depth practical knowledge of the applicable regulations and guidance.
  • Auditing Knowledge: Demonstrates intermediate to advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity. Lead auditing experience strongly preferred.
  • Science Knowledge: Possess the necessary science education and knowledge to manage related clinical trials and to assure ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states
  • Communication Skills: Must professionally, clearly, concisely and consistently communicate to external and internal customers via phone, e-mail, fax, and written documents. Must also be able to demonstrate professional presentation skills deliver fair balanced presentations and, when applicable, facilitate resolution of differing opinions.
  • Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution with internal and external stakeholders to ensure adherence to quality standards and timelines.
  • Project Management Skills: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.

  • Organizational Skills: Must be able to prioritize work effectively to meet timelines.
  • Interpersonal Skills: Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
  • Computer Skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.

LICENSES/CERTIFICATIONS:

  • ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional.

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Requires up to 30% travel.

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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