Local Safety Responsible

CPL

Dublin, Dublin West

On behalf of our client, a global pharmaceutical company, we are currently looking to recruit a Local Safety Responsible. Reporting to the Medical Director you will be responsible for fulfilling the role of Local Safety Responsible (LSR) for Ireland ensuring that collection, reporting and handling of safety information associated with company products is performed according to global company and local regulatory requirements. As LSR you will be required to manage and maintain oversight of safety risk management and all other pharmacovigilance (PV) activities. You will be responsible for ensuring PV compliance and inspection readiness across all affiliate functions. Working with a PV Executive you will be responsible for the management of all Local Safety Activities. Key Activities and Responsibilities Management of Individual Case Safety Report (ICSR) from all relevant sources (solicited and unsolicited sources); Local Signal Detection for local products (i.e., products without global product support), where applicable; Oversight of Risk Management Plan Implementation; Safety Communication including the management of safety queries, acting as a point of contact for local Health Authorities and maintaining oversight of Direct Healthcare Professional Communication. Study and Program Oversight ensuring appropriate safety reporting processes are in place for global and local interventional clinical trials, Non-Interventional Studies (NISs), Post Authorization Studies (PASS/PAES), Market Research and Patient Support Programs (MAPs), Pre-Approval and Post-Trial Access Programs and Compassionate Use in accordance with company policies and procedures, global and local regulatory requirements. PV Quality ensuring the implementation and maintenance of a PV Quality System in the affiliate. Full responsibility for educating and training relevant personnel in the affiliate and promoting PV standards across the local affiliate. Local PV Agreement management to ensure all contracts meet required PV medial compliance. Skills Profile/Experience. Healthcare professional (medical degree preferred, pharmacist or nurse) is required. Life sciences graduate with significant experience in PV (especially operational PV) may be considered. A post graduate qualification is an advantage. A minimum of 5 years PV experience required, with at least 3 years of that PV experience within an affiliate/local country office setting of a biopharmaceutical company preferred. Demonstrated leadership skills required. Good organisational skills with excellent attention to detail and the ability to think strategically. Good understanding of the drug development process, proven ability to acquire knowledge in different disease and therapeutic areas and knowledge of medical terminology. Excellent knowledge of the EU PV legislation and experience of practically implementing the requirements. Experience in and knowledge of other Medical related functions (e.g. Clinical Research, Medical Information and Regulatory Affairs etc.) is required. Experience working cross functionally. 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