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Pharmacovigilance and Medical Quality Lead
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
- Reporting to the Head, Good Pharmacovigilance Practice Quality Operations, you will 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 identify compliance risks and recommend mitigations
- Partner with various Takeda R&D functions and external parties including contract auditors and investigator sites to promote 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 help teams to be inspection ready, to support 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 procedures; assess impact of audit findings on subject safety, data integrity, and business operations.
- You will 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 comply with applicable regulations.
- Develop risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP, GVP and Takeda 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
- You will facilitate investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
- Help manage 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 inspection responses and follow-up actions.
- Analyze metrics for assigned programs to development teams and GMQ management; recommend any required actions and monitor implementation.
- Escalate systemic or essential 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.
- 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 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.
- Demonstrate 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.
- Understands the phases, processes and techniques used to implement a clinical development program.
- Understand the medical/therapeutic impact of products.
- Have the necessary science education and knowledge to provide QA oversight of clinical trials and pharmacovigilance activities, and to assure ethical treatment of subjects. Understand medical terminology and is familiar with standards of care and disease states.
- Risk management expertise, including issue identification, decision making, and risk mitigation.
- Demonstrate proficiency in negotiation and conflict resolution.
- Must communicate to our customers by phone, email, fax, and written documents. Must also be able to provide fair balanced presentations and, when applicable, facilitate resolution of differing opinions.
- You can manage complex projects, delivering all expected deliverables on time, and communicating changes in pre-established goals and deadlines.
- Can work with other personalities in a respectful manner that is conducive to goal achievement and team building.
- Will use the computer hardware and software programs provided to manage deliverables and to communicate with our team members.
- Certified Quality Auditor, ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.
- Willingness to travel to various meetings and audits, including overnight trips. Some international travel may be required.
- Requires infrequent travel.
- This role will be posted for both the Boston and Zurich market. You will be asked to be located within reasonable range of either location or be willing to relocate.
Location and Salary Information:
This job posting excludes CO applicants.
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- 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 and company match of charitable contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement
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, or any other characteristic protected by law.
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.