Senior Pharmacovigilance Associate

  • Location
    Newry, Antrim
  • Salary
    £ 23000 - £ 25000 / Year
  • Job type
  • Industry
    Science and Research
  • External Reference
  • Category
    Science - Biomedical Engineering

Applications are invited for the position of a Pharmacovigilance Associate within the Regulatory department. The successful candidate will be reporting to the Pharmacovigilance Manager/Deputy QPPV. should have at least one years' experience in a Veterinary Pharmacovigilance role. should be educated to a third level qualification OR have at least 2 years' experience in a busy administrative 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, PSUR compilation and other Pharmacovigilance activities.

� To provide a high level of administrative support to the QPPV and Pharmacovigilance Manager.

� To provide support to junior staff members.

� To ensure compliance with Standard Operating Procedures (SOPs), whilst adhering to the operational requirements and legislation appointed by Regulatory Authorities.

� To liaise with Regulatory Agencies, Distributors and Norbrook personnel on Pharmacovigilance issues (including quality investigations) daily, ensuring queries are responded to in a timely manner.

� Accurate data entry including the receipt and processing of global adverse event reports and follow-ups on the Pharmacovigilance database, ensuring timely submission to 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, Safety Call (USA) and the Quality dept.

� To assist in the maintenance of global staff training records.

� 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

� At least one years' experience in a Veterinary Pharmacovigilance role.

� Educated to a third level qualification OR have at least 2 years' experience in a busy administrative role.

� Highly organised with experience working in a busy office environment.

� Ability to work well under pressure and on their own initiative, whilst demonstrating a high degree of accuracy.

� Have a meticulous approach, attention to detail and excellent communication skills.

� Must be computer literate with excellent knowledge of Microsoft Word and Excel software packages.

Full time, Permanent Location:

Newry, Co. Down Remuneration:

Salary Attractive Benefits: Free Life Assurance, Company Pension Scheme, 30 days annual leave, Wedding Leave, Employee well-being initiatives, Healthcare plan, Company Sick Pay, Employee Assistance Programme, on-site free parking, Canteen Facilities, Employee Perks scheme, Discounted Car Insurance, Annual Employee raffle, employee recognition scheme, career development opportunities and much more

Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.

By applying for this role your details will be submitted to Adecco. Our Candidate Privacy Information Statement explaining how we will use your information is available on our website.

To speak to a recruitment expert please contact Neil McCallum