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Form of workJob Title: PV Dossier Management Specialist
Max Rate : (USD)50/hour bill
Serve as specialist responsible for ensuring electronically compliant PV reports,
availability of data required for the generation of PSR reports, and ensuring the
distribution and submission tracking activities for PSRs is performed. Actively
contribute to the development and implementation of improved Sanofi PV report
processes as appropriate; oversee outsourced activities (eg QC, training/mentoring
etc).
Interface with PSR stakeholders to: coordinate outputs from the sanofi safety database
(AWARE), extract sales data (IMS), obtain partnership data (SDEA), and regulatory and
clinical outputs. Oversee the preparation of the AWARE PSR Package in accordance
with internal procedures to meet regulatory requirements. Support the review,
approval and notification process of reports published in DOMASYS.
Provide DOMASYS/DOMEX and publishing support for all PV reports to include RMP
publishing. Act as DMS expert for eCTD, PV report publishing, EU PSUSA procedure,
SHARE, PSR WIN and DOMASYS Template coordination. 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.
Manage the submission tracking activities for periodic reports to support the timely
distribution and submission to all relevant destinations. Perform submission activities
for CAP products. Liaison with GRA to ensure delivery of package and signed originals
in a timely manner. Ensure tasks and activities are performed according to the Work
Instructions, procedures and policies in place. Participate in the writing of quality
documents related to PVDM activities.
Skills:Computer literacy especially in Windows based programs
Ability to effectively troubleshoot issues
Ability to prioritize and multitask
Excellent communication skills
Strong attention to detail and interpersonal skills within or outside department
Previous experience working on PSRs
Working knowledge of ICH guidelines concerning the production and submission of
PSURs and of EU Clinical Trial Directives
Document Management System experience and training
Core Dossier Training
Education:BA or BS preferred
4 - 6 years of Pharma or related experience in document support/coordination
activities
Understanding of technologies involved (specifically Advanced MSWord/MSExcel,
Documentum, Core Dossier, and Acrobat)
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