Safety Physician at Biomapas

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Safety Physician at Biomapas. Join our global Pharmacovigilance team as a . Safety Physician. .. Safety Physician. is responsible for monitoring and evaluating the safety profile of clinical trial products throughout their lifecycle in phases. This role will play a critical role in ensuring patient safety by analyzing and interpreting safety data, contributing to the risk management process, and supporting regulatory submissions for post-marketing.. Position is in . any EU country.. Responsibilities:. Safety Data Evaluation:. Review and assess Clinical trial safety Reports, adverse events, SUSARs for potential safety signals. Analyse and interpret clinical safety data to identify potential risks associated with drug products. Provide medical input for the preparation of safety reports, including Development Safety Update Reports (DSURs), and Annual safety reports (ASRs). Risk Management:. Contribute to the development and implementation of risk management strategies for drug products. Participate in the continuous monitoring of the benefit-risk profile of assigned products. Provide medical insights for the creation of safety-related labelling changes. Signal Detection and Management:. Participate in signal detection activities and contribute to signal evaluation and management processes. Conduct medical assessments of signals and recommend appropriate actions. A minimum of a bachelor's degree in medical, biomedical science. At least 5+ years of experience in safety and pharmacovigilance within the pharmaceutical or Contract Research Organization (CRO) industry. Oncology and immunology background is mandatory. Experience in clinical trial safety and medical review of adverse events with knowledge of global PV regulations.[NI2.1]. Proficiency in both verbal and written English and Local language is preferable. Strong expertise in MS Office applications. Attention to detail and strong analytical skills. Problem-solving skills, particularly in identifying and mitigating health risks. Company Location: Czechia.