Drug Safety Quality Specialist
Drug Safety & PharmacovigilenceBothell,
The Drug Safety Quality Specialist is responsible for supporting the development and maintenance of Drug Safety processes and procedures that ensure compliance with global regulatory requirements. This position also participates in the development and maintenance of Drug Safety process training, including the support of training delivery to Drug Safety and cross-functional personnel as required. In addition, the position assists in monitoring adherence to Drug Safety processes and procedures, PVA agreements, and SMPs.
+ Independently manage the process that guides the authoring, review/approval, and change management of Drug Safety process documents in partnership with cross-functional departments
+ Independently manage the process that guides the authoring, delivery and change management of all training on Drug Safety processes and procedures in partnership with Drug Safety and cross-functional stakeholders
+ Maintain training matrices/role-based curriculum for Drug Safety staff
+ Participate in audit/inspection activities in close partnership with Manager, Drug Safety Quality and Research and Development Quality Assurance
+ Perform root cause analyses for late reports and participate in investigations of deviations
+ Monitor of core compliance metrics and/or Drug Safety activities to ensure compliance with regulatory reporting timelines and Drug Safety processes
+ Perform periodic quality review and take part in data review to identify opportunities for process improvement
+ Perform other duties related to the position as required
+ 5+ 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
+ Bachelor's degree
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visitwww.seattlegenetics.com.
Seattle Genetics 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.