My client, an expanding pharmaceutical organisation are seeking a Drug Safety Executive to join their team in South Tipperary. This role will work closely alongside the regulatory team in Ireland and report in to the European Director of Regulatory and Drug Safety in the UK.
Duties of the role include:
- Fulfill the role of Deputy Qualified Person for Pharmacovigilance in line with European legislation
- Assist with the implementation and maintenance of the pharmacovigilance quality system with regard to legislation, guidelines and regulatory requirements
- Assist with audit activities to fulfill pharmacovigilance requirements
- Maintain the company’s Pharmacovigilance System Master File
- Conduct pharmacovigilance training with all of the companies personnel
- Assist with preparing and updating pharmacovigilance agreements with business partners
- Assist with preparing, hosting and follow up of regulatory authority inspections
- Level 8 Degree in Life Sciences or Pharmacy
- A strong and clear understanding of European, international and local pharmacovigilance requirements including Good Pharmacovigilance Practice (GVP)
- Minimum of one year experience in a similar role
For additional information and a confidential discussion on this and similar opportunities contact Lee on: 056 7786631 / 085 8072559
All applications will be dealt with in the strictest confidence and your CV will never be released without your prior approval.
Job Ref Number: LD-18909