A client in the Pharmaceutical industry is currently recruiting for a Drug Safety Officer
The client company is the leading and fastest growing branded generic company in Ireland. The Company manufactures liquids, creams/ointments and powders under its own licenses in Ireland, which are distributed to its international markets directly from its facility located in Tipperary.
The client company currently hold over 200 prescriptions and over the counter formulations licensed in various markets globally.
Maintain Pharmacovigilance System Master File
Assist with the implementation and maintenance of the pharmacovigilance quality system with regard to legislation, guidelines and regulatory requirements
Assist with preparing and updating pharmacovigilance agreements with business partners
Assist with audit activities to fulfil pharmacovigilance requirements
Conduct pharmacovigilance training with all personnel
Assist with preparing, hosting and follow up of regulatory authority inspections
Qualifuifications & Experience:
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
Good understanding of GVP, System Administration, Training