Reporting to the Senior Vice President, Risk Management & Pharmacovigilance, the Director, Drug Safety Operations is responsible for the operational management and oversight of case processing activities performed internally and externally by vendors (CROs), expedited safety reporting and business partner data exchange. The successful candidate will be responsible for ensuring all ICSR processing is in compliance with regulatory requirements and corporate and departmental procedures. This position requires ability to influence without directly managing and partnership with internal and external colleagues in matrix teams and with senior management. It also requires the supervision and management (goal setting activities) of internal safety operations personnel.
Subject matter expertise on safety operations and overall data quality during audits/inspections
Continuous improvement and maintenance of internal and external case processing (e.g., quality evaluations and metrics)
Provide functional support / input to Alliance Management in setting up vendor relationships (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans (SMP))
Oversight of Drug Safety Quality Management, Case Management / Compliance and Infrastructure in the generation, review and approval of governing documents, such as SOPs, Work Instructions / Training Guides and ensure operational implementation
Oversight of Alliance Management in the generation of Pharmacovigilance Agreements
Along with Drug Safety Quality Management, review Business Partner timelines and quality metrics to ensure the exchange of safety information are in line with Pharmacovigilance Agreements
Ensure timely submission of expedited safety reports and other external submissions through effective vendor (SMP) management and performance metrics review
Partner with Drug Safety Quality Management, to identify deviations and CAPAs required to address late reporting
Provide oversight and support of the Drug Safety Database System Owner
Provide Drug Safety Operational support to Safety Evaluation and Risk Management, Clinical Development Operations, Data Management and other Clinical Development Teams as needed
Develop adverse event receipt and processing structure in preparation for product market launch; partner with medical affairs to implement post market AE reporting strategy
Managing internal Drug Safety Operations personnel including goal setting and providing Manager Performance Evaluation Assessments
Other responsibilities as required
Master’s or Doctorate level degree in health care related profession
Minimum of 8-10 years in Drug Safety / Pharmacovigilance in biotech or pharmaceutical industry setting
Minimum of 3 years’ experience working with CROs, vendors, and business partner relationship management
Successful leadership / senior level experience in global pharmacovigilance operations with pre-and post-approved products
Experience with selection and working with contract service providers for case processing, aggregate reporting and quality management activities
Experience in performance management of PV systems
Experience with regulatory inspections and company audits including FDA and MHRA/EMA PV inspections
Demonstrated experience working with cross functional areas with effective negotiation skills
Excellent management and interpersonal skills
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 visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Internal Number: 2018-205
About Seattle Genetics
Revolutionary science meets transformative cancer therapy.
Seattle Genetics is the largest global oncology biotechnology company based in the Pacific Northwest. We are focused on developing and commercializing a new generation of targeted, empowered antibody-based therapies that have the potential to change the foundation of treatment for people with cancer.