Pharmacovigilance Specialist

ProQuest
Full time Full day
Ann Arbor, MI

Dialog Solutions a ProQuest Company– Who we are…


Our technology and services, combined with our unrivaled access to the world's best peer-reviewed literature databases makes research more powerful and efficient for any industry or application. This means we enable better research across a number of different industries and use cases.


Pharmacovigilance Specialist


What will I be doing?


The remote Pharmacovigilance specialist performs pharmacovigilance services such as biomedical literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs and therapeutic areas, and pharmacovigilance regulations. This position will be apart of our Dialog Solutions department at ProQuest.


In this position, you will also…



  • Critically analyze large numbers of articles from biomedical published literature and internal drug safety alerts and identifies individual case safety reports (ICSRs) as well as other potential safety-relevant information impacting the risk-benefit and/or safety profile of customer's products, as per applicable regulatory requirements and standard operating procedures.

  • Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article.

  • Demonstrate understanding of the client's drug labels and uses that knowledge effectively when performing the safety assessments.

  • Complete drug safety reviewing of each biomedical literature batch in a timely, thorough, and accurate manner in accordance with client's standards of timeliness and quality.

  • Use the drug safety system to track all actions and assessments in an audit-ready reference history.

  • Select articles specific to client's interest for inclusion in client's product literature database per guidelines.

  • Write accurate, detailed, and complete abstracts of selected articles using good judgment regarding the level of detail required and excellent organization, grammar, and syntax.

  • Extract key points of articles and creates comprehensive and detailed indexes of the abstract contents to ensure precise and complete retrieval of literature from client's database.

  • Ensure timely completion of indexing and abstracting of articles for assigned drugs in accordance with regulatory submission deadlines.

  • Maintain an awareness of new drugs and new therapeutic categories, new disease entities, and changes in biomedical terminology in the published literature.

  • Participate in other duties such as searches and terminology maintenance according to business needs and per the training provided.


You might be a fit if…


1)You thrive in completing tasks that require exceptional attention to detail.


2)You possess excellent initiative and judgment skills


This job may not be a fit if...




  1. Time management is low on your list of priorities



  2. You are not well organized, and you do not consider yourself as a taskmaster.


Qualified Candidates must have…



  • Bachelor's degree in a life science or healthcare-related field plus a minimum of 2 years of reviewing biomedical literature for adverse event reporting or equivalent combination of education and experience (i.e. an information science degree with at least 2 years of relevant working knowledge of supporting drug and patient safety).

  • Strong analytic ability to analyze and summarize the main points of biomedical case reports, studies, or specific topics. Excellent attention to detail. Excellent writing skills to support creation of succinct, accurate, and precise summaries. Science/medical writing background preferred.

  • Excellent English language skills (comprehension, speaking, reading and writing).

  • Working knowledge of biomedical terminology, drugs and therapeutic areas.

  • Experience with commercial and client-specific biomedical literature databases.

  • Flexibility and adaptability to changing client needs.

  • Ability to work effectively, independently and collaboratively.


Superstar Candidates will ALSO have…



  • Master's degree of higher in Nursing, Pharmacy, Medicine or related discipline.

  • Certification from a professional medical writers' association.


Other Important information about this role…



  • This is a remote position.

  • Work is performed in an intuitive web-based reviewing platform.

  • Work is subject to documented guidelines and rigorous QC.

  • Training on client's specific SOPs will be provided but is not a substitute for prior experience.

  • This position requires weekday (Monday - Friday) attendance with some scheduling flexibility available around core working hours.

  • Check out ProQuest's Dialog Solutions website to learn more

  • https://dialog.com/what-we-do/


More to love about becoming a ProQuest employee!



  • Forbes Ranks ProQuest among 2018 America's Best Mid-Size Employers

  • We offer professional development opportunities with a significant focus on learning

  • Our employee population is smart and highly collaborative

  • All of our employees have access to ProQuest research products including e-books, genealogy and academic journals

  • We offer excellent benefits!


At ProQuest, we work hard and have fun doing it. If you are an experienced Pharmacovigilance Specialist and are looking to make a difference, please apply today!


EOE/M/F/Vet/Disabled


Link for Forbes Best Mid-Size Employers: https://www.proquest.com/about/news/2018/Forbes-Ranks-ProQuest-Among-Americas-Best-Mid-Size-Employers.html


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