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Pharmacovigilance and Medical Quality Lead
- Lead Quality Assurance activities for assigned post-marketing clinical activities under the Chief Medical Office including the management of audits, quality issues and their investigations, and inspections.
- Provide expertise and guidance on Good Clinical Practice (GCP) and GVP (Good Pharmacovigilance Practices) and applicable regulations to post-marketing clinical activity performed under the Chief Medical Office to proactively identify compliance issues/risks and recommend mitigations
- Partner with various Takeda R&D functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs;
- Develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance.
- Manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP, GVP, and Takeda policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations.
- Provide expertise in GCP and GVP compliance interpretation, consultation, training, and recommendations to assigned program teams and leadership. Ensure implementation of strategies to align with governing processes, procedures, quality standards and vendor oversight activities required to maintain compliance with applicable regulations.
- Develop and implement risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP, GVP and Takeda policies and procedures. Audits require advanced auditing skills and may involve technically complex assignments.
- Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to Global Medical Quality (GMQ) management.
- Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
- Facilitate investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
- Assist with management of GCP and GVP health authority inspections; lead clinical teams in preparation for announced inspections and provide GCP and GVP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate and timely inspection responses and follow-up actions.
- Analyze, report, and present metrics for assigned programs to development teams and GMQ management; recommend any required actions and monitor implementation.
- Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
- Perform additional GCP and GVP related activities upon request by PVMQ management, including aspects of vendor qualification.
EDUCATION, EXPERIENCE AND SKILLS:
- Bachelor’s Degree required; Advanced Degree preferred.
- Minimum BS/BA degree with advanced scientific degree preferred.
- Minimum of 10 years of increasing responsibility in pharmaceutical, GCP- and/or GVP related Quality environment.
- In-depth knowledge of the applicable GVP/GCP regulations and ICH Guidelines.
Knowledge and Skills:
- In-depth knowledge of the applicable GxP and GVP regulations and guidance and ICH Guidelines.
- 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.
Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program.
- Understands the medical/therapeutic impact of products.
- Possesses the necessary science education and knowledge to provide QA oversight of clinical trials and pharmacovigilance activities, and to assure ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states.
- Demonstrates strong leadership skill and the ability to influence others.
- Risk management expertise, including issue identification, problem solving, decision making, and risk mitigation.
- Demonstrates proficiency in negotiation and conflict resolution.
- 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.
- 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.
- Certified Quality Auditor, ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
- Requires infrequent travel.
This job posting excludes CO applicants.
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.