Senior Associate, Global Patient Safety
- Remote, Home Office, United States
- Employees can work remotely
- Department: Global Patient Safety
Aurinia exists to make a difference in transforming people’s lives by delivering innovative treatments to patients living with serious, rare autoimmune and inflammatory diseases. From the earliest days of the company, we’ve applied an inventive, thoughtful, and responsible approach to developing therapies for people in need. Through our dedication, we relentlessly preserve and execute with integrity to reach our main objective, to improve patients’ health.
In addition to driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are also actively pursuing a broader portfolio of innovative drugs for autoimmune disease.
Our strategy leverages the skills and knowledge of our incredible team and our deep experience in principled drug development and commercialization. Aurinia provides a working environment where individuals can thrive in a professional, creative, and inspirational atmosphere. Together, we are driven to make an impact for our patient communities as advocates and partners in innovation.
Day-to-day case processing activities for post-marketing and/or clinical study reporting. Performs safety review of adverse event reports entered in global safety database, including QC and consistency checks. Performs case flow monitor activities to ensure cases are moving through the workflow in a timely manner to prevent late reporting to regulatory authorities. Develops safety expertise in assigned products/indications. Ensures collaboration with cross-functional teams including communication of safety updates and issues. In collaboration with safety physician, alerts appropriate management as soon as a possible signal/trend is recognized.
- Daily review of global safety database including triage and evaluation of assigned cases in the Aurinia workflow for case analysis and query management
- Performs individual case review of both serious and non-serious cases entered in Aurinia’s global safety database with source documents in effective quality check practices.
- Identifies and documents Data Entry errors
- Communicates with CRO/PV vendor on QC findings
- Communicates with CRO/PV vendor on case queries
- Develops standard PV targeted queries for unique adverse events of special interest (AESIs) or “signal” reports in collaboration with Safety Physician.
- Responsible for presenting overall case listing summary in GPS team meetings, with a focus on cases requiring specific discussion/decisions
- Review dashboard metrics to perform case workflow monitoring activities and identifying cases that are non-compliant with the internal workflow timelines
- Communicates with CRO/PV vendor and medical reviewers regarding cases that are non-compliant with the internal workflow timelines
- Supports GPS management in identifying areas of quality concern including workflow timelines, data entry errors, data entry inconsistencies and reporting timelines.
- Active member of GPS team in both writing and review of processes and plans across CRO/PV vendor studies and projects
- Identifies case management processes that are inconsistent or not well defined and communicates this to GPS management
- Provides input to GPS management on suggested process improvements in case management processes
- GPS representation/meeting attendance in cross functional meetings with CRO/PV vendor (regular standing meetings and ad hoc, post-marketing and clinical)
- Maintains case files per GCP in an “audit ready” state.
- Liaise with other areas of global pharmacovigilance systems and participate in staff training globally as needed
- Assist in coordinating tables and listings for various Regulatory reports (DSURs, Annual Report, PSURs, Five-Year Renewal for EU), i.e. QC Line Listing, update data base if needed, assure data base is complete and accurate, preliminary tally of reported cases, and draft report segments as needed.
- Gain increasing product and GPS process knowledge and competence (safety profile, US, and EU Regulatory requirements and processes for post-marketing safety).
- Compile, review with Line Manager, and forward routine monthly trending summary for PV Quality activities.
- Lead the daily management and review of the Aurinia Safety Mailbox including case triage, assessment and issue escalation to GPS team members as required
- Maintain Aurinia-sponsored SAE/Narrative tracker for internal use
- Keep GPS team informed of any potential safety trend or program process issue and participate in process improvement if needed
- Be familiar with global regulatory requirements for safety data processing and reporting and translating these requirements to Aurinia procedures.
- Supports inspection readiness projects.
- Willingness to perform other duties as required.
- Bachelor’s degree (or equivalent) in health-care related field (strongly preferred).
- Minimum of two years industry experience with concentration in Global Patient Safety highly desirable and/or advanced degree in related field.
- At minimum, a basic working understanding of drug safety filing procedures
- Competent knowledge of domestic and international PV regulatory requirements highly desirable.
- •Excellent writing and verbal communication skills.
- Must be experienced with Microsoft applications, and clinical/safety database applications.
- Good communication skills
- Highly organized
- Detail oriented
- Functions well in a cross functional team
- Strong interpersonal skills
- Able to prioritize tasks and multi-task appropriately
All candidate information will be kept confidential according to EEO guidelines.