The Quality Assurance and Compliance Pharmacist monitors and assures compliance to State and Federal Rules and Regulations, FDA requirements, manufacturer contractual Adverse Event and Product Complaint clinical requirements and completes general Quality Assurance Checks.
- Participates in Adverse Event, Product Complaint, and REMS internal investigations.
- Manages Medication Guides: Monitoring FDA website for revisions, facilitates internal system updates, and automated insertion in the litpak.
- Provides contracted AE/PC support: Provides clinical review of contractual AE and PC definitions.
- Conducts State Board of Pharmacy research and investigation, providing information used to develop guidance and internal stances with a variety of compliance and regulatory requirements.
- Acts as MedWatch administrator – facilitates meetings, prints reports and faxes reports to FDA.
- Monitors new medications added to system, validates product specific information is in place, and develops new product clinical pearls, PPI, and Med Guide insertion.
- Provide REMS support – creates and annually updates REMS practice standards, reviews REMS training annually to validate they are relevant.
- Other duties: clinical research, investigation, and oversight as deemed appropriate.
- Graduate of ACPE Accreditation School of Pharmacy with a B.S. Pharmacy or Pharm D, degree.
- 5-8 years of experience.
- Current resident pharmacist license in good standing.
- Advanced problem solving skills and the ability to work collaboratively with other departments to resolve issues.
- Good oral and written communication skills
- Ability to read and interpret prescriptions.
- Strong focus on customer service, quality and compliance.
- Ability to manage timelines and meet tight client deadlines.
- Ability to adapt in a changing environment.
- Ability to work a flexible schedule for peak volume times.
ABOUT THE DEPARTMENT
Through the range of healthcare products and services Accredo offers, team members provide in-depth care for patients with chronic health conditions like hemophilia, oncology, rheumatoid arthritis and growth hormone deficiencies. In addition to the wide range of healthcare products offered to these patients, we provide comprehensive management services, including outcomes measurement, counseling, clinical care management programs, social services and reimbursement services. In these very high-touch roles, employees leave every day knowing they made a positive impact on patient lives.
Job Id: REQ20010139