Medical Officer Pharmacovigilance Drug Safety

Published: 6/14/2022

Healthcare

Job Description

Saratoga Medical (DBA Saratoga Ascend) is hiring Senior Medical Officer – Pharmacovigilance & Drug Safety for onsite opportunities in Rockville, MD. Package includes competitive rates and long-term federal contract opportunities.

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.

Job Description:

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.

Required Qualifications & Documentation:

MD from an accredited university.
Minimum 10 years of relevant experience.
U.S. work authorization required (No visa sponsorship).
No security clearance required.
Experience in Pharmacovigilance, Drug Safety, Medical Monitoring, or Sponsor/CRO safety monitoring preferred.

Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation, or any other term or condition of employment on the basis of race, religion, color, age, sex, national origin, or disability, provided the employee can perform the essential functions of the position with or without reasonable accommodation.