Pharmacovigilance Associate - Newry, United Kingdom - Norbrook Laboratories
Description
In Norbrook we pride ourselves in being one of the top companies in Northern Ireland andone 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.
The Pharmacovigilance Associate will be responsible for providing high levels of
administrative support to the Pharmacovigilance Manager, as well as processing reports of
adverse events and responding to queries in a timely manner.
Main Activities/Tasks
- Undertake a range of administrative duties on behalf of the QPPV and
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
- To ensure compliance with Standard Operating Procedures (SOPs), whilst adhering to
- To liaise with global Regulatory Authorities, Distributors and Norbrook personnel on
queries are responded to in a timely manner.
- Accurate technical data entry including the receipt and processing of global adverse
- timely submission to global regulatory authorities in compliance with internal procedures
and global legislation.
- To ensure compliance with internal departmental procedures and Key Performance
- To assist in the maintenance of the Pharmacovigilance QMS and associated
- 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
- To assist with the reconciliation of adverse event reports from Distributors, satellite
- To assist with the maintenance of global staff training records.
- To assist in the preparation and maintenance of global PhV Agreements liaising with
- To assist with internal and external Pharmacovigilance inspections.
- To carry out any other Pharmacovigilance duties deemed necessary by management.
Essential Criteria:
form in order to be considered:
- Educated to a third level qualification or have at least 2 years' experience in a busy
- 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
- Must have a meticulous approach, attention to detail and excellent communication skills.
- Must be computer literate with excellent knowledge of Microsoft Word, Excel and
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
***- Applicants should be able to provide proof that they have a right to work in the UK at the
considered.
Benefits:
- Free Life Assurance
- Onsite free parking
- Company Pension Scheme
- Canteen Facilities
- Healthcare cash plan
- Employee Perks scheme
- 31 days annual leave Discounted Car Insurance
- Wedding Leave
- Annual Employee raffle
- Company Sick Pay
- Employee Recognition scheme
- Employee wellbeing initiatives
- Career development opportunitie
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