Pharmacovigilance Quality Management and Compliance Associate

On behalf of our client , a global pharmaceutical company, we are recruiting for a Pharmacovigilance Quality Management and Compliance Associate role. This is a permanent position.

Role:

• Implement and administer Pharmacovigilance quality management systems to ensure best practice and continuous improvement of the Pharmacovigilance department.

Support safety data reporting processes and procedures and ensuring compliance with national legislation

Quality Management Systems:

• Support the Pharmacovigilance Quality Management and Compliance Manager (PV QMCM) in ensuring that detailed systems and procedures are in place in accordance with Group Guidelines, Policies and Procedures and relevant guidelines of external regulatory and professional organizations.
• Support in the provision of training on QMS policies and procedures for all appropriate personnel and departments on a continuous basis.
• Compile monthly and annual compliance reports and document and investigate all non-compliances.
• Identify trending on root causes and ensure responsible persons/departments implement adequate and timeous corrective and preventative action (CAPA).
• Support in the management of a self-inspection programme of regular audits of Quality Systems internally and where relevant affiliates, externally.  Provide regular reports and feedback to relevant management to ensure continuous, effective operation of Quality Management Systems. 
•  Assist in the regular monitoring of Safety Data Exchange Agreements to ensure compliance with Quality Systems Management process and procedure.
• Maintain Key Performance Indicators for all relevant internal and external departments/organizations as required by the business.
• Ensure that the aim of continuous improvement is achieved.
• Keep abreast of developments in best practice, inspection trends and all QMS related activities.
• Responsibility for supporting personnel in compliance related activities and tasks, and supporting supervision of operations across PV group.
• Review, monitor and ensures relevant actions are taken from the monthly reports as agreed.

Pharmacovigilance (PV):

• Comply with local PV QMS documents in accordance with Group Guidelines, Policies and Procedures, IMB guidance, EU legislation and guidelines.
• Support the PV QMCM in the maintenance of a local PV deviation management system.
• Ensure knowledge of responsibilities regarding PV, in line with all applicable legislation and guidelines.
• Ensure individual case safety reports are reported within stipulated timelines.
• Ensure archiving individual case safety reports and relevant documents are in accordance to Group Guidelines and EU legislation
• Support the PV QMCM in the maintenance of the local PV quality system, including PV agreement and appendices (product lists) are up to date.
• Ensure review and compliance tracking is carried out for individual case safety reports and all aggregated reports submitted to the national authority.
• Reporting of Key Performance Indicators regarding safety.
• Reporting to national authorities, if required.
• Participation in Team meetings.
• Ensure knowledge of responsibilities regarding pharmacovigilance, in line with EU legislation and guidelines.
• Support in the review of listings and aggregated reports to ensure that these are accurate, complete and comprehensive.
• Assist the PV QMCM in conducting review and gap analysis on new Pharmacovigilance regulations, guidance and produces recommended plans for implementation within the company.

Training:

• Liaise with PV QMCM to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance safety activities.

Other responsibilities:

• Compliance with relevant company policies, guidelines and procedures.
• Awareness of  Group Goals and Objectives.
• Work towards the continuous development and improvement of the department.
• Effective utilization of resources (this includes financial impact).
• Work effectively and efficiently.
• Execute other duties as may be required by management, as training & experience allows.

• Strive to uphold Group core values.
• Adherence to Company Health & Safety procedures
• Participate in training programmes
• Any other duties as assigned by your Manager

Requirements

• Life Sciences or Pharmacy degree.
• Previous Pharmacovigilance Quality Management experience is an advantage.
• Report writing.
• Information gathering and monitoring.
• Projects (advantage).
• Excellent oral and written English communication
• Highly organized and flexible
• Decision making
• Attention to detail
• Problem solving

For a full Job Spec and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671