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Drug Safety Publishing Specialist

Edison-New Brunswick Metro Area, New Jersey

Post Date: 05/02/2017 Job ID: JN -052017-18965
  • Pharmacovigilance Publishing Specialist
    BA/BS with 4+ years of experience in drug safety PV reporting, eCTD, Puslishing
    PV Publishing Specialist specializes in the publishing:
  • Serve as specialist responsible for ensuring electronically compliant PV reports
  • Actively contribute to the development and implementation of improved PV report processes as appropriate.
  • Support the review, QC, approval and notification process of reports published in DOMASYS.
  • Provide DOMASYS/DOMEX and publishing support for all PV reports to include RMP, Adhoc Safety Reports, PSMF publishing.
  • Act as DMS expert for eCTD, PV report publishing, DOMASYS Template coordination, other report publishing related projects
  • Responsible to deliver on time published reports to PSR customers in required format.
  • This involves troubleshooting issues raised by DMS, and providing ad hoc user support to GPE collaborators in the use of DMS and advanced features of MSWord.
  • Ensure tasks and activities are performed according to the Work Instructions, procedures and policies in place. Participate in the writing / updating of quality documents related to PV Publishing activities.

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