US-MA, Sr. Manager Pharmacovigilance Quality Assurance 1700295-MZ
Senior Manager, Pharmacovigilance Quality Assurance
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.
Implement of 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.
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 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
Collaborate with GxP colleagues in QA groups and with colleagues at TDC to deliver joint audits (i.e. at the GMP-PV interface and validation, computer system audits)
Provide input into SOP updates and review all TDC, TPC Global SOPs for PV
Collaborate with PV Departments within all assigned Takeda LOCs, Regions, for the development and delivery of PV training programs
Maintain up-to-date knowledge of PV legislation requirements and communicate and actively liaise with PV Departments within Takeda Europe Region locations to exchange information on emerging Regulatory requirements, industry trends
Maintain an active interest in industry trends through networks, training opportunities and professional conferences and forum.
B.Sc. in Science, Nursing, or related scientific field. M.Sc. preferred.
Minimum of 7 years in regulated pharmaceutical environment
Minimum of 5 years experience in a regulated QA environment
Minimum of 5 years of experience of auditing internal and external quality systems, including experience of GxP regulatory authority inspections
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.
ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred
Willingness to travel to various meetings or client sites, including overnight trips. Some international travel will be required.
Requires approximately 50 % travel
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