Senior Manager Drug Safety Quality
The Manager of Drug Safety Quality is responsible for developing and managing the maintenance of Drug Safety processes and procedures to ensure compliance with global regulatory requirements. This role monitors adherence to Drug Safety processes and procedures, Pharmacovigilance agreements, and Safety Management Plans and oversees the staff responsible for performing quality monitoring and documentation activities. In addition, the Manager of Drug Safety Quality serves as the department point of contact and provides guidance and operational support for audits and inspections of Drug Safety processes and procedures.
- Develop and maintain a Drug Safety Quality System and operationalize it across the Drug Safety Department.
- Oversee Drug Safety global quality processes in conjunction with the QPPV and Research and Development Quality Assurance.
- Manage the authoring, review/approval, and change management of Drug Safety process documents in partnership with cross-functional departments within and outside of Drug Safety.
- Participate in cross-functional review of global regulations to determine if process changes are required.
- Guides and supports the authoring, delivery and change management of all training on Drug Safety processes and procedures in partnership with Drug Safety and cross-functional stakeholders
- Manage and maintain training matrices/role-based curriculum for Drug Safety staff
- Serve as department liaison for audit/inspection activities in close partnership with Research and Development Quality Assurance
- Manage the authoring and review/approval of audit/inspection responses in close partnership with Research and Development Quality Assurance; manages the development, review/approval, tracking and completion of Drug Safety staff actions required to fulfill audit/inspection response commitments
- Partner with Drug Safety Project Manager to ensure alignment and compliance of PVAs and SMPs with Drug Safety processes
- Continuously refine aggregate ICSR quality review processes based on trending of results and work with other Drug Safety functions to drive quality issues to resolution
- Support vendor oversight by monitoring key performance indicator (KPI) metrics and quality/ timeliness of deliverables.
- Monitor core compliance metrics and/or Drug Safety activities to ensure compliance with regulatory reporting timelines and Drug Safety processes
- Identify and champion process improvements, and develop, track and complete action plans in partnership with Drug Safety staff and external stakeholders and update documentation and training as required
- Manage Drug Safety process deviations and CAPAs in alignment with corporate processes
- Oversight and management of Drug Safety Quality Specialists including goal setting and providing Manager Performance Evaluation Assessments
- Perform other duties related to the position as required
- Strong communication (verbal and written) skills a must
- Demonstrated leadership responsibilities in previous role (s)
- Experience managing staff and/or contract workers
- Comparable experience in the pharmaceutical industry experience preferably in one or more of the following areas: Drug Safety, Clinical Operations, or Regulatory Affairs
- Demonstrated experience working cross functional areas with strong negotiation skills
- 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, 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.