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Job Details

GCP/Pharmacovigilance Inspection Manager

Company: Thornshaw Recruitment
Location:
Reference: TD9255
Closing Date: 02 Jan 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

On behalf of our client we are hiring for a GCP/Pharmacovigilance Inspection Manager to join the team.

Requirements:

On behalf of our client we are hiring for a GCP/Pharmacovigilance Inspection Manager to join the team.

ROLE SUMMARY

 Reporting to the Inspection Manager, the role of the Good Clinical Practice (GCP)/Pharmacovigilance (PV) Inspection Manager is to manage, develop and operate the GCP/PV inspection processes; to achieve required levels of performance; and to respond effectively to changes in the internal and external environment.

The GCP/PV Inspection Manager carries out GCP/PV inspections and scientific evaluation across the full range of sites in accordance with the requirements of GCP and Good Vigilance Practice (GVP), as defined in national legislation and in EU Directives, Regulations, national legislation and guidelines.

 

Strategic Management 

Supporting the Inspection Manager in the management and ongoing development of the

GCP/PV inspection team

Providing leadership, support and direction to the GCP/PV inspection team

Providing input on the direction of the GCP/PV inspection team for inclusion into the annual business plan for the Compliance department

Working to ensure that the strategic and operational goals set for GCP/PV inspections are achieved

Supporting the development and maintenance of integrated processes across the inspection teams to ensure the strategic and operational goals of the Compliance department are achieved

Operational Management 

Managing and supervising the GCP/PV inspection team 

Working with the Inspection Manager to plan and organise work tasks to ensure efficient delivery of work

Coordinating the allocation of work and resources within the GCP/PV inspection team

Managing the day to day delivery of work within the GCP/PV inspection team

Providing support to all staff in the GCP/PV inspection team 

Promoting a positive, open, friendly and professional working environment

GCP/PV regulation

Fostering and maintaining a cohesive GCP/PV inspection team ensuring all inspectors develop their skills 

Will ensure, preparation of papers and representation of  GCP/PV inspection team at relevant committees and working groups, including follow-up on and communication of any relevant issues that may arise

Liaising with GCP/PV colleagues in other competent authorities

In conjunction with the Inspection Manager develop and implement an effective and efficient review process of inspection reports within the GCP/PV Inspection team

Review inspection reports where required

 

QUALIFICATIONS AND EXPERIENCE

 

To be considered for this post, candidates must have:

 3rd level degree qualification in a relevant scientific or healthcare discipline A minimum of three years’ work experience in at least one of the following areas:

Managing clinical trials 

Assuring the safety of clinical trial subjects .

Assuring the quality of clinical trial data. 

Good knowledge of current GCP and GVP requirements.

Own transport and a valid full driver’s licence.

Experience in managing people or leading teams.

Inspection / audit experience.

Good computer literacy.

The requisite knowledge and ability, suitability and administrative capacity for the proper discharge of the appointment 

In addition to this the ideal candidate will also have.

Post graduate qualification in a relevant scientific discipline.

Experience in the area of pharmacovigilance, preferably in auditing of pharmacovigilance systems

Excellent interpersonal skills.

Excellent communication skills (written and oral).

A strong customer service focus and be adaptable to organisational needs.

Be a self-starter, capable of excellent communication and decision making

Availability to travel for national and international inspections is a requirement in this role

 

For more information and to apply for this role please call Tina on +353 1 2784671 or e-mail tdunne@thornshaw.com

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

Apply for this job: GCP/Pharmacovigilance Inspection Manager

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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