This job has expired

Associate Director Aggregate Reports

Employer
Seagen
Location
Bothell, Washington State
Salary
Competitive pay, 401k, Medical/Dental/Vision benefits
Closing date
Jul 30, 2022

View more

Position
Bioinformatics Analyst
Category
Biotechnology
Hours
Full Time
Education
BS
You need to sign in or create an account to save a job.

Job Details

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: 

  • Serve as Seagen’s primary contact and expert for aggregate reports 
  • Provide direction and educate Seagen staff on regulations and unique reporting requirements in new territories and countries where Seagen seeks market approval 
  • Ensure aggregate reporting processes and procedures are complete and compliant with current regulations globally 
  • Provide leadership and direction to cross-functional report authors and contributors 
  • Interact and communicate effectively both 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 
  • Collaborate with Global Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Safety Statistics, etc) contributing to aggregate safety reports 
  • Manage Aggregate Reports team including the distribution of assignments, prioritization of tasks and mentorship/training as required 
  • Oversight and management of aggregate reporting team members including goal setting and providing Manager Performance Evaluation Assessments 
  • Manage 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 report deliverables from the safety and clinical databases  
  • Assist in preparation and support of audits and inspections as related to Aggregate Reports 
  • Liaise with Regulatory Affairs to coordinate synchronization of aggregate reports 
  • Provide 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 teamwork loads 
  • Demonstrated experience in people management including oversight, motivating, and developing people.  
  • Demonstrated knowledge of US, EU and international regulatory/safety regulations and guidelines 
  • Understanding 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: 

  • Bachelor’s degree or higher, 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. 

Company

Seagen is a global biotechnology company that develops and commercializes transformative cancer therapies. We’re driven by a singular mission—to make a difference for people impacted by cancer.

As an industry leader in antibody–drug conjugate (ADC) technology, we pioneered the science of harnessing antibodies designed to deliver cell-killing agents to cancer cells. Three of our four approved medicines are built on this technology.

We also focus our research efforts on novel targeted small molecule therapies. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents.

Find Us
Website
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert