Safety Surveillance Support Specialist

VenescoFort Detrick, MD

About The Position

Venesco LLC is seeking a Safety Surveillance Support Specialist to support pharmacovigilance and clinical safety activities by processing safety reports, monitoring adverse event information, maintaining safety databases, and supporting regulatory reporting requirements.

Requirements

  • Bachelor's degree in Life Sciences, Nursing, Public Health, or related field.
  • Minimum 3 years of pharmacovigilance or drug safety experience.
  • Familiarity with Argus or similar safety systems.
  • Knowledge of FDA and ICH safety reporting requirements.

Responsibilities

  • Monitor safety email inboxes and reporting systems.
  • Receive and triage adverse event reports.
  • Process safety cases and follow-up information.
  • Support MedWatch and regulatory reporting submissions.
  • Reconcile clinical and safety databases.
  • Maintain safety documentation and records.
  • Support DSMB preparation and logistics.
  • Assist with safety trend analysis.
  • Support annual safety reports and study closeout activities.
  • Ensure documentation is inspection ready.
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