Reporting to the Director of Drug Safety Operations, the Manager, Drug Safety Operations Case Management is responsible for the operational management and oversight of case processing activities performed internally and externally by vendors (CROs). The successful candidate will be responsible for ensuring all ICSR processing complies with regulatory requirements, corporate and departmental procedures and applicable pharmacovigilance agreements.
Ensures all case management activities comply with regulatory requirements, corporate and departmental procedures and applicable Pharmacovigilance (PV) agreements
Serves as the expert on all aspects of case management activities and makes decisions in accordance with global regulations, guidelines and industry best practices
Identifies methods to improve efficiency, accuracy and compliance of case management
Participates in the development and operational implementation of case management governing documents such as SOPs, work instructions, Safety Management Plans and Pharmacovigilance Agreements
Leads oversight of case management vendor including training, evaluation of quality and issue management
Contributes to the development and implementation of strategic direction for the case management team including identifying resource needs and allocation
Provides appropriate representation during regulatory inspections, internal audits and partner audits
Collaborates cross-functionally as well as internally with Drug Safety Medical Reviewers and Drug Safety Signal Evaluations and Risk Management personnel
Accountable for recruiting, mentoring, and coaching of direct reports by providing leadership and an environment that encourages ongoing professional development
R.N, B.S.N, RPh or PharmD
Minimum of 5 years in Drug Safety / Pharmacovigilance in biotech or pharmaceutical industry setting
Minimum of 3 years direct report management
Extensive understanding of PV regulatory environment with working knowledge of FDA and global regulations
Proficient in safety systems (e.g., Argus, ARISg, etc.).
Working knowledge of MedDRA coding
Demonstrated experience working with cross functional areas with effective negotiation skills
Exceptional communication skills, both written and verbal
Excellent management and interpersonal skills
Drug Safety / Pharmacovigilance experience with an emphasis on oncology within a Clinical Trial setting
Vendor oversight and business partner collaboration experience
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: 2018-247
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.