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PV Associate

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Marketing

Projektbeschreibung

Case Processing:

Definition: The completion of full case information on the database, culminating in Quality Review to ensure accuracy and completeness.

Activities Include:

*Triage of incoming cases to determine seriousness for prioritization of daily workflow (to be discussed re triage specialist)
*Confirmation of Safety Co-ordinator case registry data
*Database searches as necessary
*Completion of literature searches as necessary
*Completion of remaining case data entry, including narrative or auto-narrative
*Completion of risk and quality (label, approval, manual coding & quality review steps
*Clarification of unclear or illegible information from the LSO or Call Centre
*Discuss source documents, coding conventions and ad-hoc queries with Medical Assessment Physician
*Completion of protocol request forms as necessary
*Preparation of deviation memo as necessary
*Request deletions as necessary
*Single case unblinding
Processes and Procedures:
Definition: Continuing awareness of company procedures and guidelines to maintain regulatory compliance.
Activities Include:
-Standard Operating Procedures and Working Practices

*Department guidance documents
*MedDRA coding dictionary and MedDRA points to consider
*Understand relevant safety implications regarding contracts with operating companies and/or marketing partners
*Review and make suggestions for system and procedure enhancements.
Project Work Audits, Inspections and other Ad-hoc Requirements:
Definition: Participation in BRM projects, preparations for audits and inspections.
Activities Include:
*Participation in inspections and audits, as required (e.g., interviews)
*Participation in local or global project teams

If you are interested in this role, please contact Jessica Warden-Brown on the details below.

The contract will initially be a 12 month contract with the possibility to extend.To find out more about Real please visit www.realstaffing.com

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Marketing/Vertrieb

  • Skills:

    marketing

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland