Job Description
Job Title: Associate Director, Global Patient Safety Clinical Operations
Job Location: California City, CA, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Director
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Job Description About the role:
At Takeda, we are a forward-looking, world-class RD organization that unlocks innovation and delivers transformative therapies to patients. By focusing RD efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
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 set up and conduct of clinical studies from a PV perspective. You will partner with key stakeholders within and outside PV to ensure continuous harmonized operations of global Pharmacovigilance activities and maintain highest standards for integrated functioning.
As part of the Pharmacovigilance Operations team, you will report to the Director, PV Clinical Operations and will be responsible for overall leadership to support global principles and standard practices for PV operational activities within clinical trials.
How You Will Contribute - Identify potential Clinical Development Program issues/risks in a proactive matter and lead discussions to mitigate them
- Perform tasks of daily study specific activities including SAE reconciliation, study set up, TMF filing
- Perform certain key tasks to ensure high data quality and efficiency
- Support study specific Inspection and Audit requests pertaining to their program
- Conduct sample quality review 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 their program
- Maintain knowledge of PV Regulations and global industry practices for PV operational efficiency and compliance
- Liaise with and advise study teams including Clinical Science, Data Management, Regulatory Affairs, and other functional areas locally/globally on matters relating to Pharmacovigilance to ensure overall compliance and appropriate standards and methodologies within the company
- Ensure consistency in collection, processing to optimize evaluation of safety data stemming from clinical trials
- 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 including detailed comprehension of global regulatory requirements.
- Good cross-cultural understanding and experience.
- Critical thinking and analytical skills and ability to make high level decisions in cross- functional and global environments.
- Ability to review, analyze, interpret, and present complex data to a high standard.
- Understanding of and contribution to Takeda business needs and global strategy.
- Able to interact with personnel from all functional areas and externally to the company at all levels and to represent the department and company in a highly professional manner.
- Good level of computer literacy with Microsoft applications.
- Excellent organization skills and ability to prioritize individual and departmental workloads.
- Multi-tasking with the ability to successfully manage multiple critical issues simultaneously.
- Take the initiative to patriciate in projects outside the direct remit of the job to enhance visibility of the department and ensure cross functional awareness of GPSE processes and standards.
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.
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.
This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy.
Takeda Compensation And Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location: Massachusetts - Virtual
U.S. Base Salary Range 149,100.00 - 234,300.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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, and any other characteristic protected by law.
Locations Massachusetts - Virtual
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time
Job Exempt Yes
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