30 days old

Clinical Advisor, Pharmacovigilance

MSC
Bethesda, MD 20814

Overview

We blend deep domain expertise in health IT, life sciences, public safety, and grants management with advanced technologies to help Federal agencies solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to cultivate a culture of innovation, customer success, and employee growth.

Duties & Responsibilities

MSC is searching for a Clinical Advisor to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Bethesda, Maryland.

 

  • Oversee all aspects of the centers Pharmacovigilance Program, which leads the process for safety signal management activities, and ensure the detection, assessment, understanding and prevention of safety events for each investigational product (IP) the center manufactures for clinical research.
  • Provide tactical leadership for the centers Pharmacovigilance Program/Team.
  • 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 centers Office of Regulatory Sciences.
  • 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 the centers external partners to gather PV information/data and review it utilizing the PV data system platform (ARGUS).
  • 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 centers manufactured investigational products to detect any change in risk profile.
  • Collaborate with the centers 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.

Requirements

  • Advanced Clinical degree required. (NP, PA, MD, etc.)
  • Minimum three (3) to five (5) years of experience in Pharmacovigilance (PV) with significant experience in preparing regulatory documents.
  • Five (5) to ten (10) years of related experience in a biotechnology, pharmaceutical company, government, or CRO environment.
  • 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.
  • Must have thorough understanding of medical terminology and ability to summarize medical information.
  • Personnel management and supervisory experience is required.
  • Strong attention to detail and follow-up skills.
  • Must be flexible and willing to take on significant administrative responsibilities.
  • Must take initiative and have ability to work independently and as a team member, offering assistance wherever needed.
  • Must be able to create contingency plans to deal with possible challenges and roadblocks.
  • Good computer and database skills, familiarity with ARGUS platform is a plus.

Medical Science & Computing (MSC), a Dovel company, is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Categories

Posted: 2020-07-09 Expires: 2020-09-06

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Clinical Advisor, Pharmacovigilance

MSC
Bethesda, MD 20814

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