Senior Medical Officer-Infectious Diseases & Pharmacovigilance with Security Clearance

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.
* 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. The annual salary range for this position is $85,000.00-$. 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.

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

* annual membership

* Employee Assistance Program

* Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and  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 qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

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