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PV Officer

Eingestellt von Advance Resourcing Ltd

Projektbeschreibung

Job Summary:

12 month FTC - Pharmacovigilance Officer - Competitive Salary
Requirements:

Title: Pharmacovigilance Officer

Location: Middlesex

Job Accountabilities:

Knowledge and use of the Pharmacovigilance database for processing of Adverse Events andAdverse Drug Reactions.
Literature searches and obtaining literature articles and reviews.
Submission of AEs and ADRs in the appropriate format to the Regulatory bodies, in compliance with the statutory timelines.
Organisation of all cases into a comprehensive documentation system.
Compilation and presentation of submission metrics.
Highlighting any areas of concern/discrepancies in the ADR arena to the Scientific Affairs Manager.
Maintain an up to date knowledge of pharmacovigilance regulations.
Pharmacovigilance training and mentoring.
SOP writing and maintenance.
Communication with internal and external customers.
Maintain contract database with all relevant documentation.
Report writing and generation of meeting minutes.
Monitoring of changes to the pharmacovigilance guidelines.
Review of SmPCs against market leaders SmPC for generic clients.
EudraVigilance reporting and reporting of expedited cases as appropriate.
Updating and adding clients products to the EVMPD (EudraVigilance Medicinal Product Dictionary).
Preparation of periodic safety update reports (PSURs) (training given).
Prepare organisation for regulatory authority PV Inspections by the MHRA, MPA, FDA including development and maintenance of SPS document, follow-up of corrective and preventative actions.
Work closely with International Quality Assurance to plan and execute the internal PV audit programme, implement monthly compliance reports, and assist with GCP Inspection.
Assist with the customisation, upgrade, and roll-out of the ARISg PV database, including the creation of User Requirement Specifications (URS), validation package, Data Entry Instructions, and associated training material.
Reporting of adverse drug reactions to regulatory authorities and affiliates.
Any other duties deemed necessary.

Working relationships

Accountable to the New Drug Development and Scientific Affairs Manager on a day to day basis.

NOTE: I am a senior recruiter within the industry across a number of job divisions for the pharmaceutical, biotech and CRO sectors. For a confidential and professional chat about your requirements/ career advice and the chance to register for free and receive weekly job updates, please call Alex on or email

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Advance Resourcing Ltd