Miloš Stojković

Medical devices safety expert within the Roche Pharma organisation, with focus on products regulated as medical devices. Global process owner and SME in the area of medical devices vigilance, involved in establishement and oversight of global safety processes incl. incident reporting, complaint management, trending and recalls, with focus on post-market space. Chair of medical devices safety policy forum.

Medical monitor and safety project lead for clinical studies across geographies and therapeutic portfolios. Medical expert in pharmacovigilance activities for a portfolio of would care biologicals and small mollecules (chronic wounds, burns, diabetic foot ulcers). Medical expert in review of technical and regulatory documentation for a range of medical devices, mainly driven by EU MDR compliance. Chair of Medical Coding Review Board for IMDRF AE coding annexes E&F.

- Medical reviewer of essential documentation incl. CER, IFU RiskMngm. - Assessment and classification of AEs and DDs in Clinical Trials across geographies and therapeutic areas, ensuring ongoing oversight of medical device safety profile. Reviewer of essential trial documentation such as protocols, eCRFs, management plans and study reports. - SME and senior medical coder of Adverse Events using MedDRA and IMDRF AE terminologies (E/F). - SME on ISO 14155:2020 and regulatory intelligence.

Master Thesis: "Use of harmonized standards for achieving regulatory conformity for medical devices in Europe" Courses included: Pharmaceutical Analysis, Pharmaceutical Technology, Pharmacology, Clinical Pharmacy/Pharmacokinetics, Plant chemistry etc.