Pv Compliance Associate

Osborne Appointments are currently working with a client and we are looking to recruit for a PV Compliance Associate to join them on a permanent basis. This is a fantastic opportunity to work with a great organisation.

Purpose of the role –

Assist the Head of PV Compliance, Training and Alliance Manager, the PV Compliance Associate will maintain quality PV Processed, procedures and data and partake in compliance monitoring activities related to Pharmacovigilance Quality Management System and other ad hoc activities where required.

Main duties/responsibilities

â?¢ Assist the Head of PV Compliance, Training and Alliance Management with monitoring the compliance of PV Quality Management Systems with current company procedures and regulatory requirements.
â?¢ Assist with internal/external Audits/Inspections, including preparation of materials and other administrative tasks as required.
â?¢ Organise and prepare minutes for meetings concerning Compliance matters.
â?¢ Complete 2-way Licensee Reconciliation for all Third Parties, where required and maintain related guidance document.
â?¢ Review of Quality Operations, Medical Information and third party Quality Complaints outputs monthly.
â?¢ Perform bi-monthly Quality Assurance of ICSRs to ensure QPPV oversight of the quality of data entry into the global safety databased.
â?¢ Produce quality guidance documents/controlled documents describing PV compliance processes.
â?¢ Quality Management system oversight activities.
â?¢ Contribute to maintenance of PV System Master File as required.
â?¢ Maintain and update contacts lists in Safety Data Exchange Agreements.
â?¢ Assist PV Compliance Specialist, where required.
â?¢ Other ad hoc tasks as assigned by the Head of PV Compliance, Training & Alliance Management

The ideal candidate will have –

â?¢ Proven and relevant experience in a Pharmacovigilance role
â?¢ In depth knowledge of Pharamcovigilance regulatory reporting requirements in European Regional countries
â?¢ Graduate level education preferred (life science, pharmacy or nursing degree would be an advantage)
â?¢ Excellent communication skills
â?¢ Ability to work well with colleagues regionally and internationally
â?¢ Strong Organisational skills
â?¢ Good attention to detail
â?¢ Ability to work independently when required
â?¢ Flexibility and adaptability
â?¢ Logical and structured thinker
â?¢ Strong written and oral communication skills and listening skills