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Job Details

Pharmacovigilance Executive.

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9688
Closing Date: 23 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a leading pharmaceutical company, are currently recruiting for a Pharmacovigilance Executive. This is a permanent role.

Requirements:

Our client, a leading pharmaceutical company, are currently recruiting for a Pharmacovigilance Executive. This is a permanent role.

Purpose

  • Assumes operational responsibility for ensuring that the collection, reporting and handling of safety information associated with company products is performed according to global company and local regulatory requirements.
  • Fulfils the role of Local Safety Responsible (LSR) back-up.
  • Fulfils the role of the Market Research and Patient Support Program (MAP) Pharmacovigilance (PV) approver which includes: the management, oversight and coordination of all PV activities in connection with local MAP process implementation. MAPs must be approved by the PV Approver before the program can commence. For the purposes, PV Approver exclusively refers to approvals of PV processes and relevant documentation and should not be confused with other persons who may approve a MAP from a functional, strategic, business or local code of practice point of view. The PV Approver in this context assesses the program design and other relevant documentation, and approves whether the program complies with the global and local PV requirements. A PV Approver must be appropriately qualified and experienced in pharmacovigilance (in particular operational and regulatory aspects of PV). A PV Approver cannot also be a MAP Lead.

Responsibilities

  • Ensures prompt and accurate responses to safety queries from internal and external sources.
  • Maintains knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development.
  • Management of Individual Case Safety Reports (ICSRs) from all relevant sources.
  • Study and programme activities.
  • PV Quality System - assumes operational responsibility for training individuals on pharmacovigilance reporting and the compliant and accurate tracking and recording this training etc.
  • If notified by the MAP Owner of any changes, check the PV language and safety reporting provisions and confirm they are accurate and complete.
  • Approve the MAP, document approval and inform the MAP Lead and/or the MAP Owner of the approval. Note: The PV Approver:
  • Confirms that the activity is a MAP.
  • Confirms that the CTV and SDQC frequencies have been correctly determined.
  • Assesses the program design, safety reporting provisions, CTV and SDQC processes contract PV language and training records.
  • The PV Approver informs either the MAP Lead or the MAP Owner, depending on who is responsible for updating the status of the program in the MAP GTT
  • Collect and process safety related data Perform CTV as per the agreed frequency for the program and document completion Perform SDQC
  • Review any changes to the MAP that may affect the PV processes and approve the MAP.
  • Perform final CTV and SDQC (if applicable) and inform the MAP Lead and the MAP Owner.
  • Confirm that the final CTV and SDQC (if applicable) have been performed and that there are no outstanding PV issues, and approve program close-out.

Requirements

  • Healthcare professional- nurse, pharmacist etc. or Life Science qualification is essential
  • Min of 2 years’ experience in similar role
  • Ability to write clear, concise, unambiguous medical text.
  • Ability to acquire knowledge in different disease and therapeutic areas.
  • Understanding of drug development process & drug safety regulatory obligations
  • Proven good communication skills with an international perspective
  • Excellent attention to detail
  • Knowledge of medical terminology
  • Excellent time management
  • Flexible.  Able to interact well within a team setting.

 

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

 

Apply for this job: Pharmacovigilance Executive.

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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