Associate Director International PV Compliance

Development Bothell, United States


Description

Position at Seagen

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:  

This is a support function based in the US with the intention to facilitate and support the EU QPPV in ensuring compliance of the Global Safety and Risk Management (GSRM) PV system with the EU requirements. 

Under the direction of QPPV and collaboration with the relevant Global and Local Seagen functions, the Associate Director, International PV Compliance will act as an operational nexus between GSRM teams, Safety International, Research and Development Quality (RDQ) and other EU functions. In addition, the International PV compliance associate director will coordinate PSMF updates, support EU related quality and compliance activities by supporting the development and maintenance of GSRM processes and procedures, and support activities in ex-US territories 

Responsibilities:  

  • Serving as the connection between the corporate pharmacovigilance (US), Safety International including the EU QPPV, and the EU HQ (Zug office) 
  • Supporting the corporate pharmacovigilance (US) in decision making on EU related requirements as a representative of the EU QPPV Office 
  • Ensuring oversight of PSMF content quality and compliance with current policies and regulations  
  • Coordinate and facilitate the review and approval of PSMF
    • Maintaining the documenting schedule of data requirements for the PSMF
    • Coordinating the kick-off call for information/email reminders to contributors ahead of due dates for submission 
    • Liaising with other global functions to collate required information within timelines 
    • Circulating the sections of the PSMF and annexes as appropriate for review 
    • Maintaining the tracker of controlled documents for inclusion in Annexes to the PSMF 
    • Uploading completed PSMF and PSMF Summary into the ECMS and ensure contributing documentation is archived in accordance with PSMF OP 
    • Supporting QPPV oversight of submission of the PSMF 
    • Maintaining the tracker of requests for the PSMF Summary and PSMF 
  • Performing additional document management activities including uploading of documents into the Veeva system as needed and providing general support to the QPPV Office 
  • Supporting ex-US regions in activities such as audits and inspections, as needed 
  • Supporting EU QPPV (office) in EU Audits & Inspections and contribute to Inspection readiness  
  • Supporting the corporate pharmacovigilance in:  
    • Ensuring compliance of internal procedures for EU requirements /integrate and align EU requirements in global procedures 
    • Writing and updating relevant GSRM Operating Procedures (OPs), Business Practices (BPs), and Job aids according to global requirements in collaboration with individual process owners 
    • Identifying further EU challenges  
    • Provide guidance to all process owners on the requirements 
  • Assisting in monitoring adherence to GSRM processes and procedures, Pharmacovigilance Agreements (PVAs), and Safety Monitoring Plans (SMPs) 
  • Collaborating with RDQ, Global Safety Compliance, EU Regulatory and other relevant Seagen functions to support Global Safety initiatives and execution in Ex-US countries/regions 
  • Perform other duties related to the position as required 

Qualifications:  

  • 6+ years of experience in Drug Safety Operations and/or related area  
  • Ability to work independently with limited supervision and/or input into work methods  
  • Demonstrated ability to manage complex processes and use experience and judgment problem solving and solution development  
  • Strong communication (verbal and written) skills  
  • Demonstrated knowledge of domestic and international regulatory safety reporting requirements  
  • Comparable experience in the pharmaceutical industry experience preferably in one or more of the following areas: Drug Safety, Clinical Operations, or Regulatory Affairs  
  • Excellent organizational skills and attention to detail  
  • Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally  
  • Excellent and proven project management skills 
  • Ability and willingness to work and coordinate activities between European and US time-zones as required 

Education:  

  • Bachelor’s degree 

 

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. 

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