Weekend Meddra Coder Jobs (NOW HIRING)

Experience 8-12 years

Investigation T1 / HSPD-12 credentialing (or interim) favorably adjudicated by DCSA prior to start. Investigation cost is covered by the Government.

Education MD or DO

Tools Argus or comparable safety database, MedWatch, MedDRA, EDMS, Microsoft Office

ABOUT THE PROGRAM

The Office of Regulatory Activities (ORA) provides regulatory and clinical support across the full life cycle of FDA-regulated medical products sponsored by the Department of Defense. This position supports ORA on site at Fort Detrick, Maryland, working alongside government scientists, clinicians, and regulatory professionals under the DHA Research and Development / USAMRDC enterprise.

THE ROLE

Provide the medical judgment behind safety surveillance for DoD-sponsored investigational products. You will lead causality and risk-benefit assessment, support Data Safety Monitoring Boards, and sign off on the safety content of regulatory submissions.

WHAT YOU WILL DO

• Provide medical review and causality assessment for adverse events and serious adverse events.
• Develop pre-market and post-market safety plans and product-specific safety surveillance plans.
• Support establishment and operation of Data Safety Monitoring Boards, including charter development and meeting support.
• Conduct literature searches, risk-benefit analyses, and comprehensive risk mitigation plans; author white papers.
• Provide strategic input on IND safety reports, annual reports, and final clinical study reports.
• Review protocols, informed consent forms, investigator brochures, and safety management plans.
• Support reporting of serious adverse events to FDA in accordance with 21 CFR 312.32 and 312.33.

WHAT YOU NEED

• MD or DO
• 8-12 years in pharmacovigilance, drug safety, or clinical development post-residency.
• Working knowledge of 21 CFR 312, ICH E2A-E2F, and GCP.
• Experience with safety databases and MedDRA-coded case review.
• Availability to support safety mailbox and escalation coverage including weekends and holidays.

NICE TO HAVE

• Board certification in a relevant specialty.
• Experience with vaccines, biologics, or medical countermeasures.