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Safety And Pharmacovigilance Advisor - Nih

10+ years
Not Disclosed
10 Feb. 14, 2025
Job Description
Job Type: Remote Education: M.Sc./M.Pharm/PhD/MD Skills:

Safety and Pharmacovigilance Advisor - NIH

Company: Kelly Services
Location: Rockville, MD, USA (Remote)
Benefits Offered: Dental, Life, Medical, Paid Time Off, Retirement, Vision

Job Overview:
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health (NIH), we offer administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the world’s leading medical research center.

We are seeking an experienced Safety and Pharmacovigilance Advisor to work at the NIH in Rockville, MD. This position is estimated to support a hybrid work arrangement, with on-site work likely one day per week.

Job Type: Long-term contract

Benefits:

  • Competitive compensation and comprehensive benefits package
  • Optional health, vision, and dental plans
  • Paid leave, paid federal holidays, and 401K plan
  • Access to NIH’s unparalleled resources and niche scientific initiatives

Responsibilities:

  • Ensure compliance with domestic and international regulatory safety reporting requirements (e.g., ICH guidelines, FDA, EU regulations).
  • Provide scientific and safety expertise to medical officers, study teams, and site investigators.
  • Review and provide input on protocols and risk management/safety monitoring plans for DAIDS-supported studies.
  • Serve as a subject matter expert on safety reporting for Clinical Trial Agreements, safety data exchange agreements, and communication plans.
  • Provide expertise in Expedited Adverse Event (EAE) reporting and safety management, including DAIDS Adverse Experience Reporting System (DAERS).
  • Offer MedDRA coding expertise and support related activities.
  • Develop and review safety-related documents, policies, procedures, and training materials for DAIDS-sponsored clinical trials.
  • Provide pharmacovigilance guidance, including safety database setup, signal detection, trend analysis, and safety report preparation (e.g., DSUR).

Requirements:

  • MD degree; a master’s or Ph.D. in a health-related field with relevant experience may also be considered.
  • Minimum of ten (10) years of safety and pharmacovigilance experience.

Application Process:
Interested candidates must apply online. A Kelly Government Solutions recruiter will review your resume and contact you if your skills match the requirements. A full job description will be provided upon selection.

Due to high application volumes, phone inquiries cannot be accepted. However, all Kelly recruiters have access to your profile, which expands future opportunities.

Employee Benefits:
Kelly offers voluntary benefits, including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, short-term disability, and a transportation spending account. Eligible employees also have access to retirement savings plans, service bonuses, holiday pay, and paid sick leave under applicable state or local laws.

For more details, visit: Kelly Perks and Benefits

About Kelly Government Solutions:
Kelly Government Solutions connects professionals with premier government agencies and top federal contractors. We provide full-time, project-based (SOW), seasonal, and surge support opportunities across multiple disciplines, including science, engineering, technology, and administration. Our team also assists with security clearance processing and career placement.

About Kelly:
At Kelly, we are committed to creating opportunities that enrich lives and careers. We employ over 300,000 people annually and prioritize diversity, inclusion, and equal employment opportunities.

Kelly participates in E-Verify and complies with state and local Fair Chance laws.