Pharmacovigilance Associate

In Norbrook we pride ourselves in being one of the top companies in Northern Ireland and one

of the top veterinary pharmaceutical companies globally. We develop & manufacture

veterinary medicines, supplying products to 120 countries globally. With a strong portfolio of

existing products and significant investment in R&D to launch new products annually, we have

opportunities for individuals to join us and develop their career in a global company.

Our business strategy is supported by our Values - Customer Value, One Team, Results

Driven, Excellence, Innovation, and Quality - and we support our employees to live the

behaviours that creates our culture. Our on-going success is based on the expertise,

knowledge and innovation of our employees. If you are interested in joining our team here at

**Pharmacovigilance Associate**

**Job Overview**

Applications are invited for the position of a Veterinary Pharmacovigilance Associate within

Pharmacovigilance Manager/Deputy QPPV. He/she should be educated to a third level

qualification or have at least 2 years’ experience in a busy administrative role. Full

Pharmacovigilance training will be provided, therefore no prior experience in this area is

required, however it would be beneficial. Preference for someone who has some experience

in the animal health industry or a regulatory environment; however this is not a prerequisite

for the role.

**Main Activities/Tasks**
- Undertake a range of administrative duties on behalf of the QPPV and

Pharmacovigilance Manager with regards to the maintenance of the Pharmacovigilance
System Masterfile (PSMF) and QMS including adverse event reporting and other
Pharmacovigilance activities.
- To provide a high level of administrative support to the QPPV and Pharmacovigilance

Manager.
- To ensure compliance with Standard Operating Procedures (SOPs), whilst adhering to

the operational requirements and legislation appointed by Regulatory Authorities.
- To liaise with global Regulatory Authorities, Distributors and Norbrook personnel on

Pharmacovigilance issues (including quality investigations) on a daily basis, ensuring
queries are responded to in a timely manner.
- Accurate technical data entry including the receipt and processing of global adverse

event reports and follow-ups on the Veterinary Pharmacovigilance system, ensuring
timely submission to global regulatory authorities in compliance with internal procedures
and global legislation.
- To ensure compliance with internal departmental procedures and Key Performance

Indicators.
- To assist in the maintenance of the Pharmacovigilance QMS and associated

documentation.
- To assist with the generation of PV data for reconciliation and signal detection purposes.
- To assist in the preparation of periodic reporting to applicable regulatory agencies whilst

liaising with the QPPV, Deputy QPPV and/or Veterinarians to ensure timely submission.
- To assist with the reconciliation of adverse event reports from Distributors, satellite

offices, external service provider(s) and the Quality dept.
- To assist with the maintenance of global staff training records.
- To assist in the preparation and maintenance of global PhV Agreements - liaising with
- the Pharmacovigilance Manager and relevant personnel within each Company.
- To assist with internal and external Pharmacovigilance inspections.
- To carry out any other Pharmacovigilance duties deemed necessary by management.

**Essential Criteria**:
in order to be considered:

- Educated to a third level qualification or have at least 2 years’ experience in a busy

administrative role.
- Must be highly organised with experience working in a busy office environment.
- Must have the ability to work well under pressure and on their own initiative, whilst

demonstrating a high degree of accuracy.
- Must have a meticulous approach, attention to detail and excellent communication skills.
- Must be computer literate with excellent knowledge of Microsoft Word, Excel and Outlook

software.

**Duration**: Full Time, Permanent

**Location**: Newry

**Additional Information**:

- This role will be based in a site that produces and handles penicillin, and as such, this role

would not be suitable for those that have a penicillin allergy.
***
- Applicants should be able to provide proof that they have a right to work in the UK at the

considered.

**Benefits**:

- Free Life Assurance - Employee Assistance Programme
- Company Pension Scheme - On-site free parking
- Healthcare cash plan - Canteen Facilities
- 32 days annual leave - Employee Perks scheme
- Wedding Leave - Employee Recognition scheme
- Company Sick Pay - Career development opportunities
- Employee well-being initiatives

**_Norbrook Laboratories Limited employs a workforce with members of all sections of _**
**_the community and is committed to appointing people purely on the basis of merit. In _**
**_accordance with our equal opportunities policy, we would particularly like t