Pharmacovigilance and Compliance Veterinary (Part-Time)

Website Ref: TPM04472

Summary:
A Pharmacovigilance and Compliance Veterinary (PCVA) is required for a pharmaceutical company in South Dublin. This is a part-time position (Tuesday afternoon, Thursday afternoon and Friday full day timeline on a weekly basis).

Responsibilities:

  • In conjunction with the Qualified Person for Pharmacovigilance (QPPV), is responsible for maintenance of pharmacovigilance and compliance systems associated with our client’s Animal Health products for the Republic of Ireland and Northern Ireland.
  • Achieve pharmacovigilance and compliance targets in line with divisional and company business strategy.
  • Build long term relationships with all relevant personnel in regulatory authorities/businesses within Ireland.
  • Manage and allocate resources effectively to ensure optimum results.
  • Represent the company in a positive and professional manner at all times.
  • Develops the pharmacovigilance and compliance aspects of the business through SMART objectives in agreement with QPPV.
  • Plans and organises time and resources effectively to meet all goals and objectives.
  • Takes ownership and accountability for activities for which they are responsible.
  • Demonstrates a sound knowledge of Animal Health products and procedures to ensure optimum results.
  • Adjusts work priorities accordingly in line with commercial requirements.
  • Complete all reports as required in a timely, accurate and consistent manner.
  • Conduct all of the activities under responsibilities (below) as required under company policy.
  • Understanding and adherence to all company policies.
  • Establishment and maintenance of a system which ensures that information about all AEs that are reported to the personnel, including its representatives, temporary staff and contract employees, is collected and collated in order to be accessible in at least one point in the EU.
  • Preparation for submission of PV reports for the (National Competent Authority) NCAs and the European Medicines Agency (EMA).
  • Ensuring that any request from NCAs or EMA for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a VMP is answered fully and promptly, including the provision of information about the volumes of sales or prescription of the VMP concerned.
  • Provision to the NCAs or EMA of any other information relevant to the evaluation of the benefits and risks afforded by a VMP, including appropriate information on post-marketing surveillance studies.
  • Oversight of the following aspects of the PV and GXP systems operated by MSD AH.
  • Quality control and assurance procedures including, though not limited to, case entry compliance checks and support of veterinary advisor colleagues with queries raised on case entry and GXP compliance checks as outlined in relevant procedures.
  • Procedures (e.g. SOPs, User Manuals, Work Instructions etc.) – preparation of procedures, review and conduct of inspections to verify adherence to them for PV and GXP.
  • Database operations.
  • Contractual agreements.
  • Compliance data (e.g. in relation to quality, completeness and timelines for expedited reporting and submission of PSURs).
  • Establishment and maintenance of a quality assurance system for GXP-related change control and normal distribution practice (temperature mapping and cold-chain compliance, warehouse compliance concerning quarantine / returns / disposal etc.) to identify and resolve non-conformances in association with the responsible colleagues (Regulatory Affairs, Customer Service etc.) through appropriate CAPAs.
  • Audits and inspections, including audit and inspection reports.
  • Induction and refresher training of personnel in relation to pharmacovigilance and GXP.
  • Adverse event management in the EEA – Timely local review and submission of Periodic Safety Update Reports to the NCA.
  • PV arrangements with third parties involved in licensing, marketing, co-marketing or distribution of VMPs in the EEA – so-called third party products.
  • Pharmacovigilance-related aspects of post-authorization studies (PAS).
  • A PAS is a study carried out in accordance with the terms of the marketing authorization management Tracking of changes to Summary of Product Characteristics (SPCs) and associated changes.
  • Technical review of promotional materials to ensure compliance with relevant IE and UK legislation and industry guidelines.
  • Support of technical advisor colleagues in reporting / resolving PV complaints and product quality complaints.
  • Support of regulatory colleagues for cases concerning quality defects (pre-market) including market-related actions and recalls.

Qualifications & Experience:

  • Registered veterinary practitioner with at least two year’s experience in general practice with a Relevant Industry Qualification.
  • Strong Planning and Organising skills.
  • In-depth knowledge of the veterinary market.
  • In depth knowledge of pharmacovigilance and good distribution practice legislation and guidelines.
  • Ability to work well within in a high performance team structure.
  • Ability to work under pressure to deadlines.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.