Drug Safety Coordinator - Nashville, TN

Sarah Cannon Research Institute•Nashville, TN

7d•Hybrid

About The Position

The Drug Safety Coordinator monitors, documents, evaluates, and reports the safety of patients participating in clinical research studies. The role is the primary pharmacovigilance contact among research sites, study teams, sponsors, and regulatory authorities, and helps protect the safety and well-being of clinical trial participants. The position develops and maintains Safety Monitoring Plans; reviews, processes, documents, and reports adverse events; maintains safety cases in the ARGUS database; writes clinical narratives; assesses whether safety events are expected and require regulatory reporting; codes medical information; submits expedited safety reports; reviews cumulative data for trends; and collaborates with medical and regulatory stakeholders. Safety activities must comply with Good Clinical Practice, ICH guidelines, regulatory requirements, and company SOPs. This is a hybrid role with two onsite days per 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.
Experience with medical data entry, including laboratory, clinical, or medical systems.
Technology skills with multiple EMR systems and MS Windows and Office, including Excel, PowerPoint, and Outlook.
Safety database experience, such as ARGUS, Aris-G, or Veeva.

Nice To Haves

Bachelor's degree highly preferred; work experience may be substituted for education.
MedDRA experience strongly preferred.

Responsibilities

Develop and maintain a Safety Monitoring Plan (SMP) describing how safety events will be identified, reviewed, and reported throughout 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 such as the FDA and to Institutional Review Boards (IRBs) or 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.