Drug Safety Publishing Specialist
Edison-New Brunswick Metro Area, New Jersey
- 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.