Takeda Pharmaceuticals
Associate Director, Global Patient Safety Clinical Operations
Takeda Pharmaceuticals, Montgomery, Alabama, United States, 36136
Takeda Pharmaceuticals Associate Director, Global Patient Safety Clinical Operations Montgomery, Alabama Apply Now
Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. Join Takeda as an Associate Director, Global Patient Safety Clinical Operations in Cambridge, MA, where you will provide functional expertise and Program level oversight and accountability of PV Activities globally, including the setup and conduct of clinical studies from a PV perspective. How you will contribute: Identify potential Clinical Development Program issues/risks proactively and lead discussions to mitigate them. Perform daily study-specific activities including SAE reconciliation, study setup, and TMF filing. Support study-specific Inspection and Audit requests. Conduct sample quality review of outsourced activities including SAE reconciliation and eTMF filling. Review and create Study level documents including Study Management Plans and Study Safety Summaries. Liaise with and advise study teams on matters relating to Pharmacovigilance. Ensure consistency in collection and processing to optimize evaluation of safety data. Represent Pharmacovigilance Operations on Global Program/study teams. Minimum Requirements/Qualifications: Bachelor’s required; degree in scientific/medical field or advanced degree preferred. 8+ years of related pharmaceutical industry experience required. Experience in SAE reconciliation and safety management plans. Demonstrated skills in negotiation and consensus decision-making. Expert knowledge of clinical trial and Pharmacovigilance methodologies. Critical thinking and analytical skills. Able to interact with personnel from all functional areas and represent the department professionally. Good level of computer literacy with Microsoft applications. Excellent organization skills and ability to prioritize workloads. Multi-tasking ability to manage multiple critical issues simultaneously. More About Us: 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. This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy. EEO Statement 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.
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Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. Join Takeda as an Associate Director, Global Patient Safety Clinical Operations in Cambridge, MA, where you will provide functional expertise and Program level oversight and accountability of PV Activities globally, including the setup and conduct of clinical studies from a PV perspective. How you will contribute: Identify potential Clinical Development Program issues/risks proactively and lead discussions to mitigate them. Perform daily study-specific activities including SAE reconciliation, study setup, and TMF filing. Support study-specific Inspection and Audit requests. Conduct sample quality review of outsourced activities including SAE reconciliation and eTMF filling. Review and create Study level documents including Study Management Plans and Study Safety Summaries. Liaise with and advise study teams on matters relating to Pharmacovigilance. Ensure consistency in collection and processing to optimize evaluation of safety data. Represent Pharmacovigilance Operations on Global Program/study teams. Minimum Requirements/Qualifications: Bachelor’s required; degree in scientific/medical field or advanced degree preferred. 8+ years of related pharmaceutical industry experience required. Experience in SAE reconciliation and safety management plans. Demonstrated skills in negotiation and consensus decision-making. Expert knowledge of clinical trial and Pharmacovigilance methodologies. Critical thinking and analytical skills. Able to interact with personnel from all functional areas and represent the department professionally. Good level of computer literacy with Microsoft applications. Excellent organization skills and ability to prioritize workloads. Multi-tasking ability to manage multiple critical issues simultaneously. More About Us: 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. This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy. EEO Statement 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.
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