Senior Medical Officer-Infectious Diseases & Pharmacovigilance Jobs

Senior Medical Officer

Job Family: Clinical Trial Operations Travel Required: None Clearance Required: Ability to Obtain Public Trust What You Will Do: We are looking for a Senior Medical Officer to support NIAID/DMID by providing infectious disease expertise, protocol development support, pharmacovigilance review, and clinical safety consultation. This is a full-time position located in Rockville, MD.

Responsibilities:

• Review pharmacovigilance reporting strategies, including safety monitoring plans and related safety documentation.
• Support protocol development activities by providing input on study objectives, subject safety, and safety reporting requirements.
• Provide clinical expertise regarding infectious diseases and make recommendations on key clinical issues.
• Serve as a clinical advisor to DMID staff and external stakeholders on study design and safety matters.
• Review incoming safety data, including adverse event reports, safety committee reports, clinical study reports, investigator brochures, package inserts, and scientific literature.
• Conduct comprehensive reviews of clinical protocols and supporting documentation.
• Provide recommendations to clinical investigators and program staff regarding protocol safety and implementation.
• Participate in discussions and presentations involving industry representatives, contractors, grantees, safety monitoring committees, and other stakeholders.
• Maintain proficiency in reviewing and accessing clinical study information from DMID-supported databases.

Qualifications:

• Medical degree from an accredited university.
• Minimum of SIX (6) years of medical, infectious disease, clinical research, or pharmacovigilance experience.
• Experience evaluating safety monitoring plans and adverse event reporting.
• Experience reviewing clinical research protocols and associated study documentation.
• Demonstrated knowledge of infectious disease clinical research.
• Proficiency with Microsoft Office applications.
• Must be able to obtain and maintain a Federal or DoD "public trust"; candidates must receive approved adjudication prior to onboarding with Guidehouse. Candidates with an active public trust or suitability are preferred.

Preferred Qualifications:

• Board certification in an infectious disease-related specialty.
• Experience supporting NIH-sponsored clinical trials.
• Experience presenting to regulatory, scientific, or executive audiences.
• Familiarity with safety monitoring committees and pharmacovigilance programs.
• Strong oral and written communication skills.
• Experience working with clinical research databases and electronic safety systems.

The annual salary range for this position is $85,000.00-$141,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

Benefits include:

• Medical, Rx, Dental & Vision Insurance
• Personal and Family Sick Time & Company Paid Holidays
• Parental Leave
• 401(k) Retirement Plan
• Group Term Life and Travel Assistance
• Voluntary Life and AD&D Insurance
• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
• Transit and Parking Commuter Benefits
• Short-Term & Long-Term Disability
• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
• Employee Referral Program
• Corporate Sponsored Events & Community Outreach
• Care.com annual membership
• Employee Assistance Program
• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
• Position may be eligible for a discretionary variable incentive bonus