Drug Safety Specialist - GPV Job at SGS Consulting, Remote

UDZzS1YwVE41VUpHMm5iUFU2VmQvYStHdlE9PQ==
  • SGS Consulting
  • Remote

Job Description

Job Responsibilities:

  • Communicates with internal and external parties on case content and replies to case-related queries.
  • Makes decisions on case processing matters for prioritization, FU significance, seriousness, listedness, coding queries, etc.
  • Initiates case corrections, as needed.
  • Approves case corrections, as needed
  • Supports late case investigations by PV COPE team
  • Performs clinical open query investigations
  • Provides support for the creation/update of training materials in collaboration with the Data Assurance Manager and PV Training team.
  • Assists in facilitating finalized training sessions (PV processes and systems) for vendors and relevant case processing staff in collaboration with the Data Assurance Manager and PV Training team.
  • Provides support to global Data Assurance teams and other internal departments, as appropriate

Skills:

  • 5+ years relevant experience within Pharmacovigilance
  • Knowledge and understanding of PV regulatory requirements and ICSR processing procedures globally and in America’s region
  • Has the ability to recommend enhancements to internal policies, processes and procedures based on new requirements, legislation, etc.
  • Present solutions to problems that require the regular use of creativity and ingenuity, while safeguarding Client’s compliance.
  • Ensures case processing and case quality are maintained at highest standards at all times
  • Strong interpersonal skills and multi-cultural /intercultural awareness; able to develop effective relationships through collaboration.
  • Good communication skills in English (written and spoken)
  • Ability to work independently in seeking materials needed for completing daily tasks.
  • Ability to work in a fast-paced environment.
  • Working knowledge of ARGUS safety database
  • Experience with Word, Excel, PowerPoint, Microsoft Teams and SharePoint sites
  • Experience with working from home

Education/Experience:

  • BS/MS degree in life sciences or equivalent (RN preferred)

Job Tags

Remote job, Work from home,

Similar Jobs

Armstrong World Industries

Chemical Process Engineer (PEDP) Job Job at Armstrong World Industries

 ...build engagement and satisfaction to deliver results. Process Engineers at Armstrong World Industries provide technical expertise to...  ...when necessary. Qualifications Bachelor's Degree in Chemical Engineering, Chemistry, Biology, Material Science or Physics.... 

PPL Motorhomes

RV Sales Representative Job at PPL Motorhomes

 ...demonstrating, and describing vehicles to buyers to include test drives, explanation of the buying process and processing of contracts for sale, calling buyers and sellers, documenting all phone and email contacts in our database, inspecting vehicles to make sure they are in... 

Gilead Sciences, Inc.

Medical Science Liaison - South Texas Job at Gilead Sciences, Inc.

* Advanced medical/scientific/clinical degree (MD, DO, PhD, PharmD, NP or PA preferred) with experience in the pharmaceutical industry...  ...knowledge to achieve the strategic business goals of USMA and Gilead Sciences.* Able to work with a high level of autonomy and independence.*... 

MaineHealth

Intern- Legal Affairs Job at MaineHealth

 ...some frequency include: administrative law, commercial transactions, employment and labor, tort/...  ...security/privacy, intellectual property, real estate and planning, probate, environmental law, municipal law, and tax law. Interns should expect to do research on a wide... 

Brasco International

Maintenance Technician Apprentice Job at Brasco International

. A MaintenanceApprentice typicallyhasthefollowingresponsibilitiesandskills: AssistwithMaintenanceTasks :Workalongsidefullyqualifiedmaintenancetechnicianstolearnandperformvariousmaintenanceduties. InstallationandRepair :Assistininstalling...