Pharmacist (FDA)

Pharmacist (FDA)

Location: Silver Spring, MD

Status: Full-time

BlackFish Federal is seeking pharmacists with expert knowledge of MedDRA coding in support of our customer, the Food & Drug Administration (FDA) to apply clinical and product knowledge in reviewing and triaging incoming Direct reports to the appropriate FDA Center(s) based on product types and safety events.

This position is in support of a contract on which we are bidding with the FDA. Any offers will be contingent on TO award.

Required Qualifications:

•Pharm.D. degree and current Pharmacy registration and up-to-date license in any of the United States required. Other advanced degree/training in public health preferred.
•The Pharmacist must possess strong current clinical/therapeutic knowledge.
•Effective communication skills with all staff members, project management team and stakeholders.
•Familiar with a wide range of products on the market regulated by different FDA Centers.
•Knowledge of MedDRA Dictionary/Coding using MedDRA® Term Selection: Points to Consider, experience preferred. (https://alt.meddra.org/files_acrobat/000571_termselptc_r4_21_mar2021.pdf)
•Understanding of FDA regulated products to be able to identify product names in an ICSR and code to a medical product dictionary like WHO Drug Dictionary.
•Experience in public health preferred.
•Ability to obtain and maintain a government security clearance.

Essential Functions:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

•Apply clinical and product knowledge in reviewing and triaging incoming Direct reports to the appropriate FDA Center(s) based on product types and safety events.
•Annotate reports as necessary to clarify key data elements such as product names and ICSR narrative.
•Prioritize urgent reports as needed and directed by FDA onsite representative.
•Interpret unclear handwritten reports, as necessary.
•Provide clear and effective oral and written communication to the team members.
•Demonstrate strong knowledge of a wide variety of products under FDA regulation and unapproved products.
•Keep up to date with new products on the market and reporting regulations.
•Help train other triaging pharmacists, as needed.
•Contribute to maintaining/updating SOP, as needed.
•Respond to data request with regards to triaging, as needed.
•Interact with other contracting personnel in registration, data entry, and coding, as necessary, to ensure the highest quality of data capturing from reports.
•Work with Central Triage Unit (CTU) staff to make sure acknowledgment letters are sent out in a timely fashion.
•Consult with the FDA Onsite Representative when encountering unusual reports, data elements, or public health incidents.
•Attend team meetings as requested.

Work Conditions:

•Work is primarily performed in an office environment.

This document is not intended to cover or contain a comprehensive listing of all job-related activities, duties or responsibilities that are required of the employee. Due to the nature of the industry, job tasks may be changed as necessary to meet the needs of the customer.

BlackFish Federal, LLC. is an equal opportunity employer providing equal employment opportunities (EEO) to all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.