Medical Officer Pharmacovigilance Drug Safety

Saratoga Medical CenterRockville, MD
Onsite

About The Position

Saratoga Medical (DBA Saratoga Ascend) has an exciting opportunity for a Senior Medical Officer – Pharmacovigilance & Drug Safety to support DMID-sponsored clinical trials in Rockville, MD. This is a great opportunity for experienced physicians seeking to provide medical safety oversight and pharmacovigilance support in a collaborative clinical research environment.

Requirements

  • MD from an accredited university.
  • Minimum 10 years of relevant experience.
  • U.S. work authorization required (No visa sponsorship).
  • No security clearance required.

Nice To Haves

  • Experience in Pharmacovigilance, Drug Safety, Medical Monitoring, or Sponsor/CRO safety monitoring preferred.

Responsibilities

  • Provides medical safety oversight for DMID-sponsored clinical trials.
  • Reviews clinical trial protocols for safety and operational issues.
  • Assesses Serious Adverse Events (SAEs) and reviews SUSAR notifications.
  • Performs medical data reviews, including laboratory values, adverse events, coding, tables, listings, and figures.
  • Represents DMID in communications with the FDA, sponsors, and academic partners.
  • Serves as a safety expert on safety committees.
  • Develops safety-related policies and guidelines.
  • Identifies process gaps and supports issue resolution.

Benefits

  • competitive rates
  • long-term federal contract opportunities
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