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Job Details

Pharmacovigilance Project Manager.

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9972
Closing Date: 12 Jan 19
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a global clinical research organisation, are currently recruiting for a Pharmacovigilance Project Manager.

Requirements:

Our client, a global clinical research organisation, are currently recruiting for a Pharmacovigilance Project Manager.

The PV project and process manager provides support for set-up of new Pharmacovigilance (PV) processes and systems, in particular in relation to company PV affiliates, databases and acquisition of new products. The PV project and process manager will also support the ongoing maintenance of these processes and operations as needed.

The PV project and process manager is largely responsible for coordinating the implementation of new products, systems and company affiliate offices into the existing PV procedures and systems. Tasks may include but are not limited to oversight of update to written procedures or agreements for integration of new products, processes and systems into the company portfolio; Act as central point of contact for all PV projects, liaising with other Group departments as the need arises; Gap analysis of existing procedures and process for integration of new products and oversight of update to existing procedures as needed.

Responsibilities

Financial:

  • Project management of contractual and financial aspects of all pharmacovigilance related projects and the effective utilisation of resources to keep processes cost effective. 
  • Identification of project challenges to departmental line management and the financial impact thereof.

Project Management:

  • Act in the capacity of project manager for PV projects. This may entail negotiating deliverable timelines, and resolving project-related issues
  • Ensure smooth intra and inter-departmental cooperation and preventing any duplication of efforts from different functions
  • Ensure that PV have robust systems and process in place with meet Group PV’s regulatory requirements in both EU, US and ROW.
  • Identify any gaps or issues within the PV systems or processes. Coordinate the development of these processes to make them more efficient without compromising the quality of the output. 
  • Responsible for the continuous improvement and implementing lean processes and SMART initiatives
  • Oversight of the integration of new systems by:
    • Identifying any gaps or issues which need to be addressed
    • Ensure written procedures are in place
    • Ensure documented training is developed and administered as per training matrix
    • Ensure any issues are raised and addressed.  Coordinate and implement improvement plans.
  • New Acquisitions and Projects
      • Point of contact for Pharmacovigilance
      • Identify what is requirements for PV
      • Plan and coordinate project to ensure PV are organised, prepared and ready for the additional workload
      • FTE assessment
      • Identifying any gaps or issues which need to be addressed
      • Ensure written procedures are in place
      • Ensure documented training is developed and administered as per training matrix
      • Ensure any issues are raised and addressed.  Coordinate and implement improvement plans.
  • PSMF
      • Provide input to the PSMF as required by EU QPPV.
  • Project management of contractual and financial aspects to be performed with management where necessary
  • Ensuring time and cost efficiencies are assessed for all PV initiatives
  • Attend internal and technical team meetings as required
  • Proactively engage with other departmental resources where necessary to ensure that information/documentation requests are delivered in a professional and timeous manner 

Training:

  • Initiate and participate in departmental or interdepartmental process improvement and training initiatives
  • Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures 
  • Coordinate and review the development of departmental SOPs/WINs
  • Oversight of training matrix
  • Ensure adequate training for PV processes are in place and update date
  • Assess training requirements for each PV job role
  • Ensure training documentation is developed and available on ALearn
  • Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
  • Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department
  • Maintain a strong knowledge of PV regulations and requirements by attending workshops and conferences.

Requirements

  • Relevant Life Science, Pharmacy or related qualification
  • Extensive Pharmacovigilance experience
  • Solid Pharmacovigilance Project management experience
  • Results and performance driven – deliver results that meet or exceed expectations
  • Sense of urgency – responding to issues and opportunities in a timely manner
  • Intellectual curiosity – willing to suggest and try new ideas

If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

#THR2018

Apply for this job:  Pharmacovigilance Project 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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