Drug Safety Specialist

-Develop project specific safety reporting procedures and workflows and provide guidance to the team on the procedures -Develop project specific safety database customization and data entry guidelines -Triage of incoming reports for completeness,

legibility and validity -Initial data entry of case reports into safety database / tracking system -Assessment of case reports for seriousness, causality and expectedness -Requesting follow-up i.e. written, telephone -Adverse event (AE) and drug coding -Writing

case narratives -Case reconciliation coordinating activities with Data Management personnel -Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc safety reports etc -Quality control of case reports, line listings and

tabulations -Maintaining local drug safety reporting requirements -Regulatory authority reporting (electronic and hard copy) -Literature reviews -Ad hoc requests / queries -Provide drug safety and project specific training -Quality Assurance activities such

as preparing for audits, development of templates, checklists and guidelines -Create and maintain project specific working files, case report files and project central files -Inform Medical Project Managers and Regional Head of PV Operations of potential changein-

scope of projects. -Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as: - drafting, writing and editing of protocols and CRFs - collection and review of endpoint packages - review and follow-up laboratory alerts

- review and follow-up patient eligibility for inclusion / exclusion in clinical trials - review and follow-up protocol violations - preparing relevant procedures covering the above medical monitoring activities - review study specific Model ICFs according

ICH/GCP criteria - Act as the Medical Monitoring Representative in project teams, as appropriate - Participate in client meetings / investigator meetings/ project specific training sessions - Delegate work as appropriate to Drug Safety Associates and Drug

Safety AssistantsQualifications-Drug safety knowledge and experience -Experience in working in drug development and/or healthcare environment