The Drug Safety Associate supports all activities related to the safety data associated with DNAtrix’s clinical trials. This person is responsible for reviewing, tracking and reporting on adverse drug experiences, and assisting with the preparation of annual and ad hoc pharmacovigilance reports. Applicants based in Texas are prefered.
Duties and Responsibilities include but are not limited to:
- Receives, follows-up and tracks adverse events, SAEs/ECIs
- Prepares Safety reports; generates data listings, tables, figures from the safety database
- Provides medical and scientific information to various functional areas within DNAtrix
- Conducts and analyzes medical and scientific literature searches
- Reviews clinical trial protocols, bioequivalence study protocols and provides input
- Responsible for effective and efficient development of the Safety Management Plan
- Performs consistent coding of diseases, adverse events, and medication according to the project-specific coding conventions; performs QC checks throughout the project
- Supports the generation of Annual Data Safety Updates, Periodic Safety Reports, etc.
- Reconciles SAEs in accordance with project specific guidelines
- Provides management of individual case reports (SAEs, ADRs), reconciliation of SAEs, coding and data retrievals from the database, supports the generation of periodic safety reports, and DSMB/DMC reviews and the generation of Integrated Analyses of Safety and Efficacy
- Generates concise, accurate and well-written case narratives
- Supports review of laboratory values, and CRF data; for safety aspects
- Delivers metrics to supervisor efficiently, accurately and within agreed-upon timelines
Experience and Skills:
- 2+ years of Drug Safety / Pharmacovigilance experience in a pharmaceutical or CRO setting is required
- Able to read and understand medical source documents and to summarize them in a well-written narrative; a good understanding of medical terminology
- Has a strong understanding of regulations relevant to the safety of drugs in development and post authorization as well as knowledge of clinical research
- Computer literate, with proficiency in MS Office including Work, Excel, PowerPoint, Outlook
- Excellent writing skills (will be responsible for generating a narrative summary of clinical data)
- Familiarity with EDC (e.g., Medidata RAVE)
- Familiarity with remote working environments; home-office established
- A BS or BA degree, preferably in life science and/or a licensed healthcare professional
Qualified candidates should forward a resume and cover letter including a statement of interest, availability, and experience in PDF format to: careers@DNAtrix.com. PLEASE, NO PHONE CALLS.
DNAtrix is an Equal Opportunity Employer.