Seagen

Associate Director Aggregate Reports

Development - Bothell, Washington

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

The Associate Director, Safety Aggregate Reports is responsible for the development, implementation, and maintenance of robust procedures for the planning, preparation and submission of high-quality aggregate safety reports, in compliance with requisite global and local regulations and requirements. This role also provides leadership and mentorship to the Aggregate Reports team at Seagen.

Principal Responsibilities:

• Serves as Seagen’s primary contact and expert for aggregate reports.
• Ensures aggregate reporting processes and procedures are complete and compliant with current regulations globally.
• Provides leadership and direction to cross-functional report authors and contributors.
• Interacts and communicates effectively internally and cross-functionally in a highly matrixed environment.
• Responsible for the implementation and management of effective structure, procedures and tools to ensure aggregate report and other functional deliverables are completed with high quality.
• Responsible for strategic oversight of aggregate safety reports for investigational and marketed products.
• Collaborates with Global Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Safety Statistics, etc) contributing to aggregate safety reports.
• Manages distribution of assignments and prioritization of tasks within the Global Safety Risk Management aggregate reporting team.
• Oversight and management of aggregate reporting team members including goal setting and providing Manager Performance Evaluation Assessments.
• Manages commitments with license partners to ensure both meet aggregate reporting requirements as per the PV Agreement between companies.
• Oversee functional specifications of data requirements for aggregate deliverables from the safety and clinical databases.
• Responsible for maintaining compliance metrics and contributes to implementation of Corrective Action and Preventive Action (CAPA) for non-compliance findings.
• Supports continuous improvement/quality system initiatives.
• Assists in preparation and support of audits and inspections.
• Liaises with Regulatory Affairs to coordinate synchronization of aggregate reports.
• Provides oversight, and training as needed, of CRO respective activities in support of high quality and timely aggregate reports.

Qualifications:

• 10 or more years of experience in Pharmacovigilance with experience in preparation and submission of periodic aggregate safety reports.
• 7 or more years of experience working with CROs, vendors, and relationship management preferred.
• Excellent organization skills and ability to prioritize individual and team work loads.
• Demonstrated experience in people management including oversight, motivating, and developing people.
• Demonstrated knowledge of US, EU and international regulatory/safety regulations and guidelines.
• Understand safety data capture in clinical trials and post marketing settings.
• Strong written and verbal communication skills.
• Ability to work under strict deadlines and changing priorities with minimal supervision.
• Excellent negotiation, conflict resolution, decision making, problem solving and critical thinking skills.
• Experience with and demonstrated success in working on cross-functional diverse teams required.
• Ability to thrive in a global matrix environment.
• Knowledge of case processing and aggregate reporting requirements.

Education:

• Bachelors Degree required (Life Sciences preferred).

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. 

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/25/2022