Associate Director, Global Patient Safety Clinical Operations

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About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D 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 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 also 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 Global Patient Safety and Evaluations (GPSE) team, you will report to Director, Global Patient Safety Clinical Operations.

How You Will Contribute

• Perform tasks of daily study specific activities including SAE reconciliation, study set up, TMF filing
• 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
• Maintain knowledge of PV Regulations and global industry practices for PV operational efficiency and compliance
• Represent Pharmacovigilance Operations on Global Program/study teams
• Identify potential Clinical Development Program issues/risks in a proactive matter and lead discussions to mitigate them
• Perform certain key tasks to ensure high data quality and efficiency
• Review and create Study level documents including Study Management Plans, Study Safety Summaries and SAE Reconciliation within their program
• Conduct sample quality review of outsourced activities including SAE Reconciliation, eTMF filling, SAE Forms and completion instructions
• Support study specific Inspection and Audit requests pertaining to their program
• Responsible for overall leadership to support global principles and standard practices for PV operational activities within clinical trials.
• Ensure consistency in collection, processing to optimize evaluation of safety data stemming from clinical trials

Minimum Requirements/Qualifications

• Ability to review, analyze, interpret, and present complex data to a high standard.
• 8+ years of related pharmaceutical industry experience required.
• Excellent organization skills and ability to prioritize individual and departmental workloads.
• Multi-tasking with the ability to successfully manage multiple critical issues simultaneously.
• Critical thinking and analytical skills and ability to make high level decisions in cross- functional and global environments.
• Expert knowledge of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements.
• Good level of computer literacy with Microsoft applications.
• Good cross-cultural understanding and experience.
• 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.
• Experience in SAE reconciliation and safety management plans.
• 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.
• Demonstrated skills in negotiation and consensus decision making.
• Understanding of and contribution to Takeda business needs and global strategy.
• Bachelor’s required. Degree in scientific/medical field or advanced degree preferred.

What Takeda Can Offer You

• Comprehensive Healthcare: Medical, Dental, and Vision
• Health & Wellness programs including onsite flu shots and health screenings
• Tuition reimbursement
• Flexible Work Paths
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Generous time off for vacation and the option to purchase additional vacation days

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" in accordance with Takeda's Hybrid and Remote Work policy.

Base Salary Range: $ 143,000 to $ 205,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S.

• 8-5-101 et seq

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
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