Posted to MedZilla on 7/24/2017


Takeda Pharmaceuticals

US-MA, Associate Director Pharmacovigilance Quality Assurance (PVQA) 1700781-MZ


 
 

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 an Associate Director Pharmacovigilance Quality Assurancein ourCambridge, MAoffice.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director Pharmacovigilance Quality Assuranceworking on the R&D Quality team, you will be empowered to lead the operations, and a typical day will include:

OBJECTIVES:
  • Serves as the Research and Development Pharmacovigilance Quality Assurance leader in the respective region. Provides quality oversight of Pharmacovigilance in the respective region, ensuring that system audits are conducted, communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented.
  • Serves as a strategic Good Pharmacovigilance Practice (GVP) resource to Takeda for its drug development activities, and takes a lead role for the preparation, conduct, and development of responses to health authority inspections of Takeda s development activities.
  • This position provides regional leadership and strategy in line with global strategic objectives. 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.

ACCOUNTABILITIES:

  • Serve as the Pharmacovigilance Quality Assurance leader in the respective region in the implementation and refinement of processes to ensure that Takeda maintains oversight of the quality of its pharmacovigilance activities in compliance with applicable regulatory requirements.
  • Collaborate with the Senior Director, Pharmacovigilance Quality Assurance, to develop and implement the strategy for regional Pharmacovigilance quality oversight to ensure that Takeda meets its sponsor and marketing authorization holder obligations to protect the safety of study subjects and patients.
  • In collaboration with R&D Pharmacovigilance Quality Assurance support the development of tactical and strategic audit plans.
  • Support the analysis of audit program results, quality issues and investigations in order to identify actionable trends and to promote a state of compliance.
  • Identify compliance issues and conduct investigations for regional pharmacovigilance activity. Elevate serious and/or systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution.
  • Manage inspection readiness activities and represent Takeda as a Pharmacovigilance quality subject matter expert during health authority inspections of the sponsor. Provides strategic direction to assure that responses are timely and appropriate to maintain Takeda s good standing with regulatory agencies. Ensure that Pharmacovigilance inspection commitments are fulfilled on time.
  • In collaboration with R&D Supplier Quality, determine acceptability of Pharmacovigilance suppliers for potential use by Takeda.
  • Serve as a member of the Pharmacovigilance Quality Assurance Leadership team, giving input to key strategic decisions.
  • Ensure strong alignment with R&D Quality Systems and Compliance and R&D Quality Services and Improvement.
  • Ensure reports and corrective actions are developed and completed within timelines mandated in Takeda procedures.
  • Act as line manager for Pharmacovigilance Quality Assurance in the respective region

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • B.Sc. in Science, Nursing, or related scientific field required. M.Sc. preferred.
  • Extensive applicable pharmaceutical and/or biotech pharmacovigilance experience with a solid understanding of GVP-related Quality Assurance.
  • GxP Knowledge: In-depth knowledge of the applicable GxP regulations and ICH Guidelines.
  • Auditing Knowledge: Demonstrates 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.
  • Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution.
  • Pharmacovigilance Development: Understands the phases, processes and techniques used to execute a Pharmacovigilance development program.
  • Product Knowledge: Understands the medical/therapeutic impact of products.
  • Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality assurance oversight for Pharmacovigilance trials and to assure the ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states.
  • Communication skills: Must communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills and deliver informative and balanced presentations and, when applicable, facilitate resolution of differing opinions.
  • Project Management: 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.
  • Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.
  • 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 preferred.
PHYSICAL DEMANDS:
  • Routine demands of an office based environment.
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel will be required.
  • Requires approximately 50 % 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.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

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Schedule

Please visit our website at takedajobs.com

 
 


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