Job Details

  • Title: Safety Data Management Associate
  • Code: RCI-35816-1
  • Location: Tampa Florida (FL) 33634
  • Posted Date: 02/23/2021
  • Duration: 6 Months
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  Job Description

  • Requires effective communication with medical team members and other department stake holders.
  • Support creating and maintaining standardized and ad hoc reports for post-marketing and clinical safety data.
  • Focus on a strong customer service with pharmacovigilance colleagues by providing timely responses to client requests for information related to safety queries.
  • Ability to complete multiple simultaneous projects with minimal supervision.
  • Ability to interface with medical personnel and to understand medical terminology preferably MedDRA.
  • Maintain a basic working knowledge of worldwide regulatory guidelines and the process to meet pharmacovigilance reporting requirements.
  • Deliver value added business results that meet quality requirements within tight deadlines as an individual or in a team environment.
  • Communicate effectively with appropriate members of the department to determine reporting needs and negotiate deliverables.
  • Manage safety team meetings and associated documentation.
Top Skills Needed:
  • Experience required with data retrieval of relational databases in a pharmaceutical environment preferably safety or clinical database packages.
  • Should possess a working knowledge of at least one of the following: SQL, SAS, I-review or report building utilities.
  • Possess an understanding of adverse event data and how it relates to pharmacovigilance.
  • Strong analytical and technical skills with an ability to work in a team environment.
  • An understanding of medical concepts, drup development and pharmacovigilance processes
  • Excellent verbal and written communication
  • Experience working with various electronic data capture systems
  • Ability to coordinate and manage multiple, cross-functional team activities, which include meeting scheduling, facilitation, documentation, tracking and quality checks
  • Experience with SharePoint Online, MS Teams, Outlook
  • It would be ideal if the candidates have a Bachelor's degree in a life science field. MDs would be overqualified. May consider PharmD if newly out of school, as this is a relatively entry-level position in drug safety