Clinical Advisor (Pharmacovigilance Analytics) - NIH - Rockville, MD

Clinical Advisor (Pharmacovigilance Analytics) – NIH – Rockville, MD

 

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, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world.  We are currently seeking a Clinical Advisor, with experience in Pharmacovigilance Analytics to work onsite with the National Institutes of Health in Rockville, MD.  

This is a long-term contract position which offers:
- Competitive salary with comprehensive benefit package
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com

 

TASKS. The contractor shall:

  • Provide expert scientific and safety-related expertise to medical officers, study teams and site investigators to include reviewing and providing comments on protocols and working with medical officers to develop risk management/safety monitoring plans for Division-supported clinical trials.
  • Ensure the most current domestic and international regulatory safety reporting requirements are used (e.g., ICH guidelines, FDA, EU and other national and international requirements)
  • Provide safety management expertise and related safety support functions to include serving as a point of contact for project officers, contractors, grantees and intramural staff participating in domestic and international studies and supporting the DAIDS (Division of AIDS) Adverse Experience Reporting System (DAERS)
  • Provide analytical expertise and daily technical support for data management activities related to: 1) DAERS; 2) clinical and safety database reconciliation; and 3) monitoring data coding consistency cross the clinical trial networks’ data centers
  • Develop pharmacovigilance practices to include signal detection and analysis of aggregate safety and adverse event data to identify safety concerns in Division-supported clinical trials.
  • Develop and/or review a variety of programmatic and/or guidance documents and reports for use by the Safety and Pharmacovigilance Team within OPCRO
  • Collaborate with data management centers and the Division-funded Regulatory Support Center Safety Office.

 

REQUIREMENTS. The contractor must have:

  • Ph.D. in Nursing Education or a related discipline. Three (3) years of specialized experience plus a Master’s degree is equivalent to a Ph.D. Five (5) years of specialized experience plus a BA/BS degree is equivalent to a Ph.D.
  • Six (6) years of experience in the healthcare professional education
  • field.
  • Experience in clinical trials, U.S. and international regulatory safety reporting requirements and knowledge of biostatistics.
  • ECFMG certification required if medical degree is from outside the United States
  • Familiarity with principles of drug safety monitoring and pharmacovigilance with knowledge of MedDRA coding principles
  • Experience in the safety review of adverse events occurring in clinical trials to enable support for expedited adverse event (EAE) reporting and safety management
  • Experience using and analyzing large datasets and databases
  • Excellent oral and written English communication skills
  • Excellent interpersonal and organizational skills and ability to interact professionally with diverse staff and international partners

 

PLEASE APPLY ONLINE.

Note that the phone number for our NIH branch is not listed.  Due to the high volume of inquiries, we regret that we cannot accept phone calls.  All qualified candidates will be contacted.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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