Clinical Operations Director for Global Patient Safety
3 days ago
Takeda, a world-class research-driven organization, is dedicated to unlocking innovative solutions for patients worldwide. Our forward-thinking approach has led to the development of life-changing therapies in four therapeutic areas and other strategic investments.
About the RoleIn this exciting opportunity as an Associate Director, Global Patient Safety Clinical Operations in Cambridge, MA, you will provide functional expertise and program-level oversight for Pharmacovigilance activities globally. Partner with key stakeholders within and outside Pharmacovigilance to ensure harmonized operations and maintain high standards for integrated functioning.
Your Responsibilities- Identify and mitigate potential clinical development program issues/risks proactively.
- Perform daily study-specific activities including SAE reconciliation, study set up, TMF filing.
- Ensure high data quality and efficiency through specific tasks.
- Support inspection and audit requests pertaining to your program.
- Conduct sample quality reviews of outsourced activities including SAE Reconciliation, eTMF filling, SAE Forms, and completion instructions.
- Review and create Study level documents including Study Management Plans, Study Safety Summaries, and SAE Reconciliation within your program.
- Maintain knowledge of PV Regulations and global industry practices for operational efficiency and compliance.
- Liaise with and advise study teams on Pharmacovigilance matters to ensure overall compliance and appropriate standards.
- Bachelor's degree required; advanced degree preferred in a scientific or medical field.
- 8+ years of related pharmaceutical industry experience.
- Experience in SAE reconciliation and safety management plans.
- Demonstrated skills in negotiation and consensus decision-making.
- Expert knowledge of clinical trial and Pharmacovigilance methodologies and global regulatory requirements.
- Cross-cultural understanding and experience.
- Critical thinking and analytical skills with the ability to make high-level decisions.
- Ability to review, analyze, interpret, and present complex data.
Takeda offers stimulating careers, encourages innovation, and strives for excellence. We foster an inclusive, collaborative workplace united by an unwavering commitment to delivering better health and a brighter future to people worldwide.
Compensation and BenefitsThis role is classified as remote under Takeda's Hybrid and Remote Work policy. The estimated salary range for this position in Massachusetts is $149,100.00 - $234,300.00. U.S.-based employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, 401(k) plan, company match, and other benefits.
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