Local Quality Responsible

CPL

Dublin, Dublin West

Our client, a leading global pharmaceutical company, are currently recruiting for a Local Quality Responsible. This is a permanent, full-time position. Purpose. Fulfils the role of Local Safety Responsible (LSR) for Ireland. Ensures that collection, reporting and handling of safety information associated with company products is performed according to global company and local regulatory requirements. Maintains oversight of safety risk management and all other pharmacovigilance (PV) activities and ensures PV compliance and inspection readiness across all affiliate functions. Responsibilities. Key Tasks include but are not limited to those activities outlined below : Management of Individual Case Safety Report (ICSR) from all relevant sources. Local Signal Detection for local products (i.e., products without global product support. Oversight of Risk Management Plan Implementation. Safety Communication. Study and Program Oversight. Management of Aggregate Report. PV Quality. Local PV Agreement. Labeling and PV Commitment. Management of the local Drug Safety unit. Requirements. Medical Degree. Other Health Care professionals can be approved by the EU Qualified Person for Pharmacovigilance (EU QPPV) on a case by case basis if medical oversight is ensured. Experience in clinical research. A post-graduate qualification is an advantage. Understanding of drug development process & drug safety regulatory obligations. Ability to acquire knowledge in different disease and therapeutic areas. Knowledge of medical terminology. Knowledge of Drug Safety regulations. Good attention to detail. For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671. This job originally appeared on RecruitIreland.com.

2199 days ago