Senior Manager Case Management Global Safety Operations
Seagen is currently offering a unique opportunity for a highly motivated individual to be part of growing Global Safety and Risk Management Team. The successful candidate will be responsible for ensuring all ICSR processing complies with local and international regulatory requirements, corporate and departmental procedures and applicable pharmacovigilance agreements. While the primary role of this position will focus on the operational management and oversight of case processing activities performed internally and externally by vendors (CROs) the ideal candidate will also provide scientific and strategic input to support efficient decision making for our Case Management Team.
- Ensures all case management activities comply with regulatory requirements, corporate and departmental procedures and applicable Pharmacovigilance (PV) agreements
- Participates in the development and operational implementation of case management governing documents such as SOPs, work instructions, SMPs
- Leads oversight of case management vendor including training, evaluation of quality and issue management
- Works cross functionally with Safety Evaluations and Risk Management, Safety Systems team, Safety Compliance, QPPV, Local Safety Officers, Clinical Operations, Regulatory Affairs and Product Quality regarding safety data collection, analysis and reporting
- Provides AE/PC training for new PSP/MR/Medical Information as needed
- Manages oversight of literature surveillance including training of vendors
- Manages oversight of reconciliation activities and regulatory authority database searches for ICSR reporting
- Supports/performs Case Processing, Submission, and reconciliation activities as required
- Serves as Case Management representative for Business Partner and vendor Operational meetings
- Participates/assists in internal/business partner’s audit and regulatory inspections
- Provides subject matter expertise in the interpretation of regulations as it relates to ICSR processing and reporting
- Manages queries from Business Partners or vendors or internal team on case processing or submission activities
- Maintains metrics on current and projected Case Management workload
- Provides strong leadership to Case Management staff, including mentorship, training, performance management and creating opportunities for professional growth
- Provide ongoing leadership in staff career development and manage staff performance and oversee assignments including goal setting and providing Manager Performance Evaluation Assessments
- Work cross-functionally to establish and maintain priorities on projects impaction the function
- R.N, B.S.N, RPh or PharmD
- Minimum of 7 years in Drug Safety / Pharmacovigilance in biotech or pharmaceutical industry setting
- Extensive experience in Clinical Trial and Post-marketing Case Management
- Proficient in safety system (Argus).
- Working knowledge of MedDRA and WHO-Drug coding
- Demonstrated experience working with cross functional areas with effective negotiation skills.
- Exceptional communication skills, both written and verbal
- Excellent management and interpersonal skills
- Vendor oversight and business partner collaboration experience
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.