Berlin, Berlin, Germany
Experience in pharmacovigilance (focus on benefit-risk assessment and ICSRs processing); Certificate in Pharmaceutical Medicine (ECPM, University of Basel); clinical experience (pediatrics, vaccinology, endocrinology).
Global Safety Leader in Bayer AG. Member of global Benefit Risk Management (therapeutic area - pulmonary medicine) responsible for monitoring safety and designing safety measures in clinical trials, as well as in post-marketing survaillance; authoring BR documents (RMPs), aggregate reports (DSURs), and HA responses. In addition to work - exploring Berlin (still, as this is a never ending story...).
Monitoring safety of cardiovascular medications (focus on post-marketing data) in terms of signal detection and risk management: screening of ICSRs and literature publications, writing signal evaluation reports, preparation of RMPs and CCDSs, contribution to periodic reports (PBRERs), responding to health authorities requests; Performing medical assessment of ICSRs (post-marketing as well as clinical trials, ARISg); Contribution to audits and inspections.
Responsible for safety in clinical trials (both developmental and post-marketing): clinical trial protocols development, ASRs/DSURs preparation, DMC/DSMB establishing, and acting as a Safety Management Team lead; A member of the team responsible for the preparation of EMA registration dossier of succesfully registered respiratory medication: specific personal tasks included participation in CCSI/SmPC and RMP preparation, as well as dealing with authority questions; Performing AEs/ICSRs medical handling (ARISg), coordinating the handling of post-marketing surveillance data in terms of signal detection, providing an input for PSURs.
Postgraduate educational projects for physicians.