Vets , Medical Professionals & Healthcare

Veterinary Advisor – Dublin

  • Contract
  • Remote
  • Dublin South
  • 41936190

PE Global is currently recruiting for a Pharmacovigilance and Compliance Veterinary Advisor for a Client site in Dublin –

11 month initial contract

 

A position is currently open for a 40% full time equivalent pharmacovigilance and compliance veterinary advisor (Tuesday afternoon, Thursday afternoon and Friday full day timeline on a weekly basis).

 

SUMMARY OF POSITION:

In conjunction with QPPV, is responsible for maintenance of pharmacovigilance and compliance systems associated with  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

 

ACTIVITIES

  • 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 all 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

R

ESPONSIBILITIES

The following responsibilities are conducted in conjunction with the QPPV

  1. a) Establishment and maintenance of a system which ensures that information about all

AEs that are reported to the personnel of Animal Health, 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

  1. b) Preparation for submission of PV reports for the (National Competent Authority) NCAs and the European Medicines Agency (EMA)
  2. c) 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.
  3. d) 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
  4. e) Oversight of the following aspects of the PV and GXP systems operated by 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

 

  1. f) Accessibility

The contact details of the PCVA or his/her designees have to be on emergency contact lists in every subsidiary and on Global level. The PCVA or his/her designee have to ensure that the contact details will be sent to the appropriate person(s) or department(s) (e.g. local and global RA) to be added to the local and global emergency contact lists, and to ensure that the emergency contact lists contain up-to date information.

The Qualified Person for Pharmacovigilance (QPPV) / Pharmacovigilance Compliance Veterinary Advisor (PCVA) have to maintain availability via mobile telephone, office or home telephone, e-mail (including access to vet-support.ie mailbox) or fax, and access to company Facebook feeds at all times. If contact is interrupted or if the QPPV is temporarily unavailable, then the voice mail of the mobile phone and/or office phone has to be checked at least once a day. The out-of-hours 24-hour telephone answering system must be audited by the PCVA in accordance with local procedures.

 

  1. g) Deputyship and Delegation of tasks

When the Designated Point of Contact for PV (QPPV) is unavailable for any length of time e.g. annual leave, illness etc. the PCVA should ensure that all Responsibilities, listed above, are undertaken by the PCVA – acting as back up QPPV. The QPPV may also choose to delegate certain of their tasks to the PCVA, after mutually agreeing this delegation. In case of delegation, the delegate(s) is/are responsible for the fulfilment of the respective delegated tasks.

 

Experience, Knowledge & Skills

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
  • Wide-ranging and sound communication skills
  • Ability to work well within in a high performance team structure
  • Ability to work under pressure to deadlines
  • Sound interpersonal skills for dealing with a wide range of people in a variety of situations
  • Ability to communicate (verbally and in writing) clearly and succinctly
  • Self starter with drive and focus
  • Sound commercial acumen with high levels of integrity and trustworthiness
  • Good presentation skills
  • Sound IT and software skills
  • Passion and persistence

 

 

Interested candidates should submit an updated CV, marked for the attention of Audrey audrey.mccarthy@peglobal.net  or  00353 21 4297900

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