Senior Medical Officer-Infectious Diseases & Pharmacovigilance
GuidehouseAbout the role
Job Family:
Clinical Trial Operations
Travel Required:
Clearance Required:
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.
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.
What You Will Need:
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.
What Would Be Nice To Have:
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.
What We Offer:
Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
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
About Guidehouse
Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment quali
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