Joy has more than 20 years experience in Drug Safety Physician roles. Joy is medically qualified. She is a UK GMC Registered Physician with Licence to Practice. She has UK Specialist Accreditation in Pharmaceutical Medicine and is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians. Her skills encompass all aspects of global drug safety from Phase I to Post-marketing including Signal management process and procedures; Safety databases - ARISg, ARGUS, BaseCon, In-house databases; Supporting filing for new indications; Writing and reviewing CTD and RMPs; Responding to Regulatory Authority queries during filing activities; Attending meetings with Regulatory Authorities; EU Pharmacovigilance regulations; EU QPPV; MedDRA coding; Defining MedDRA Baskets for cumulative reviews; PSURs, PBRERs, DSURs, ICSRs medical reviews; Safety in clinical trials; Post-marketing safety; PASS; Compiling/reviewing safety sections CDS/SPC/IB in line with Regulatory Guidance.