|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:
- Act as Research and Development Pharmacovigilance Quality Assurance 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 implemented.
- Support Management to serves as a strategic Good Pharmacovigilance Practice (GVP) resource to Takeda for its drug development activities, and takes a supportive role for 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.
- Together with the Regional Lead of Pharmacovigilance Quality Assurance 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.
- 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.
- Obtain audit responses from Pharmacovigilance and external partners/vendors and evaluate proposed corrections, corrective actions, and/or preventative actions for compliance with applicable regulations, guidelines, and Takeda policies. Facilitate risk mitigation and escalate inadequate audit responses to management.
- Provide support, guidance and training to external contract auditors, review plans and audit reports.
- Contribute to the development of process improvement initiatives that enhance regulatory compliance and PV QA efficiencies.
- Support PV regulatory inspections
- This position supports the ongoing development and operational success of the PV Quality Assurance function.
- Review and approve observations, reports, and ratings of audits conducted and written by direct reports in PV Quality Assurance.
- Ensure reports and corrective actions are developed and completed within timelines mandated in internal procedures. Provide appropriate risk analysis for key stakeholders to make critical decisions.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- B.S. in Science, Nursing, or related scientific field.
- Minimum 6 years of applicable pharmaceutical drug development/clinical experience
- Minimum 3 years of PV-related Quality Assurance experience.
- In-depth knowledge of the applicable regulations and guidances.
- 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.
- 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.
- 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.
- Interpersonal: 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.
- ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional.
- Routine demands of an office based environment
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 50 % travel.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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.