Drug Safety Coordinator - Nashville, TN
Sarah Cannon Research Institute•Nashville, TN
•Hybrid
About The Position
The Drug Safety Coordinator monitors, documents, evaluates, and reports the safety of patients participating in clinical research studies. The role serves as the primary pharmacovigilance contact between research sites, study teams, sponsors, and regulatory authorities, helping protect clinical trial participants. This is a hybrid position, with two onsite days each week at the corporate offices in Nashville, Tennessee. Relocation assistance and visa work sponsorship are not available.
Requirements
- At least 3 years of professional experience in a clinical research, pharmaceutical, or life sciences environment using scientific, medical, and regulatory terminology.
- Technology skills with multiple EMR systems, MS Windows, and Microsoft Office, including Excel, PowerPoint, and Outlook.
- Experience with safety databases such as ARGUS, Aris-G, or Veeva.
- Medical data entry experience in laboratory, clinical, or medical systems.
Nice To Haves
- Bachelor's degree is highly preferred; work experience may be substituted for education.
- MedDRA experience is strongly preferred.
Responsibilities
- Develop and maintain a Safety Monitoring Plan describing how safety events will be identified, reviewed, and reported during a clinical trial.
- Review and process adverse event (AE) and serious adverse event (SAE) reports.
- Enter and maintain safety cases in the ARGUS safety database.
- Write clear clinical narratives explaining patient safety events.
- Determine whether safety events are expected or unexpected and whether they require regulatory reporting.
- Code medical information using industry-standard dictionaries such as MedDRA and WHO Drug.
- Prepare and submit expedited safety reports to regulatory agencies, including the FDA, and to Institutional Review Boards (IRBs) and Ethics Committees.
- Review cumulative safety data on an ongoing basis to identify trends or emerging risks.
- Collaborate with medical monitors, study chairs, sponsors, and regulatory teams to evaluate patient safety.
- Ensure safety activities comply with Good Clinical Practice (GCP), ICH guidelines, regulatory requirements, and company SOPs.
Benefits
- Comprehensive benefits supporting physical, mental, and financial well-being.
- Competitive compensation package.
- An annual bonus or long-term incentive opportunities may be offered.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
