Cardinal Health Nurse, Individualized Care (Nurse - Adverse Events) in Lewisville, Texas
What Individualized Care contributes to Cardinal Health
Delivering an exclusive model that fully integrates direct drug distribution to site-of-care with non-commercial pharmacy services, patient access support, and financial programs, Sonexus Health, a subsidiary of Cardinal Health, helps specialty pharmaceutical manufacturers have a greater connection to the customer experience and better control of product success. Personalized service and creative solutions executed through a flexible technology platform means providers are more confident in prescribing drugs, patients can more quickly obtain and complete therapy, and manufacturers can directly access more actionable insight than ever before. With all services centralized in our custom-designed facility outside of Dallas, Texas, Sonexus Health helps manufacturers rethink how far their products can go.
What is expected of you for success in your role
The Pharmacovigilance (PV) nurse is responsible for serving as a central point of contact to facilitate all aspects of clinical support encompassed in the Pharmacovigilance program. In this role, the nurse will represent and act on behalf of the pharmaceutical manufacturer in support of one or more pharmaceutical products.
What is expected of you and others at this level in Clinical Operations for functional success
- Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results.
- Uses deep subject matter expertise, influence and process skills to help the enterprise clients and stakeholders identify and meet their high priority needs while considering cultural and diversity implications.
- Demonstrates deep expertise of supported client; collaborates with COE to identify the drivers leading to business success.
- Manages day-to-day operational processes; develops and implements procedures in response to changing business needs and program design.
- Diagnoses problems related to daily transactional processes; determines possible resolutions and implements effective solutions in a timely manner.
Accountabilities in this role
- Work closely with consumers, healthcare providers (HCPs), pharmacies, Sonexus Health associates, the manufacturer’s employees, third party vendors and other service providers to ensure the accurate, complete and timely submission of safety reports (follow up adverse event reports) to the appropriate entity within the stipulated time frame.
- Responsible for inbound and outbound call handling, and for receipt and processing of e-mail and other electronic communication.
- Responsible for the submission of letters requesting follow-up information on previously reported adverse events.
- Responsible for the identification, intake, documentation and submission of all Adverse Event Reports occurring in patients who are taking or have previously taken manufacturer’s product.
- Submit all adverse event reports to manufacturer/third party vendor within stipulated time frame; additionally, follow up with HCPs, consumers, etc. if requested to do so.
- Provide identification, intake, documentation and submission of all reported Product Complaints.
- Responsible for strict adherence to approved call guidelines and approved information in all verbal and electronic correspondence.
- Responsible for clearly and promptly documenting all communications and outcomes in the appropriate location in the database.
- Perform other activities related to internal initiatives and/or the manufacturer’s program as assigned.
- Responsible for adhering to program guidelines for appropriate escalation of inquiries/correspondence to Clinical Nurse Supervisor, as well as to client when appropriate.
- Responsible for triaging to third party vendors, or fulfilling (based on specific roles assigned to the program) Medical Information inquiries from consumers, HCPs and other entities, including but not limited to, requests for product information, inquiries about side effects, guidelines for appropriate use of product, etc.
Keywords: Pharmacovigilance, Drug Safety Nurse, Safety, regulatory – adverse event report
- 5 years of nursing experience in a clinical setting
- Previous experience with Pharmacovigilance and/or Clinical Trials preferred
- Registered Nurse with current Texas license with no license restrictions
- Experience in Telehealth Nursing preferred
- Experience with Microsoft Office products including Word, Outlook and Excel
- Experience with adverse event reporting and use of a drug safety database preferred
- Bilingual Spanish preferred
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.