Clinical Advisor, Pharmacovigilance

Location
Bethesda, MD
Posted
Sep 09, 2020
Closes
Sep 24, 2020
Ref
225978
Function
Administrative, Other
Industry
Other
Hours
Full Time
Job Summary/Company: Our client, a medical sciences company that partners with various federal agencies, is looking for a Clinical Advisor, Pharmacovigilance to join its team. If you have a background in clinical studies and pharmacovigilance functions, please submit your resume and give us a call at 202-463-5100.

Responsibilities:
  • Oversee all aspects of the Pharmacovigilance Program in order to lead the process for safety signal management activities and ensure the detection, assessment, understanding and prevention of safety events for each investigational product manufactured for clinical research.
  • Provide tactical leadership for the Pharmacovigilance Program/Team.
  • Participate on cross functional, multidisciplinary teams and contribute to defining aggregate reporting guidelines.
  • Draft, review and finalize PV data agreements with collaborators who receive VRC- manufactured investigational products.
  • Work with external partners to gather PV information/data and review it utilizing the PV data system platform (ARGUS).
  • Create and adapt pharmacovigilance procedures based on prevailing domestic and international regulations, center polices/procedures, etc.
  • Review safety events for completeness and trends; analyze comprehensive safety data in consultation with PV team; communicate findings to the Office of Regulatory Sciences.
  • Author/provide strategic input or oversight for PV related sections of periodic regulatory documents (i.e. IND annual reports, DSURs, IB updates) according to the agreed process and timelines.
  • Monitor and evaluate safety profiles of the center's manufactured investigational products to detect any change in risk profile.
  • Collaborate with the center's protocol operations, medical, quality and risk management teams to ensure coordinated and effective risk mitigation strategies throughout the product lifecycle.
  • Assign projects and set deadlines for PV Team staff and facilitate PV team meetings.
Qualifications/Background Profile:
  • Advanced Clinical degree required (NP, PA, MD, etc.).
  • Minimum 3-5 years of experience in Pharmacovigilance (PV) with significant experience in preparing regulatory documents.
  • At least 5-10 years of related experience in a biotechnology, pharmaceutical company, government, or CRO environment highly preferred.
  • Personnel management and supervisory experience is required.
  • Knowledge of clinical trial and PV methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements in PV.
  • Experience with MedDRA and drug coding reviews.
  • Strong experience in the conduct and management of clinical trials, especially phase I - III vaccine or monoclonal antibody clinical trials. Strong background in clinical trial drug safety is required.
  • Good computer and database skills, familiarity with ARGUS platform is a plus.

Qualified candidates should send their resume AND call Sparks Group for additional details. Please note, resume must include a valid email address in order to be considered. We look forward to discussing your background, your current job search, and your potential career path with Sparks Group!

Sparks Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, pregnancy, citizenship, family status, genetic information, disability, or protect veteran status.

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