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Medical Director, Patient Safety And Pharmacovigilance
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- Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases.
- Provide the medical and clinical expertise needed to perform medical review of Individual Case Safety Report (ICSR) mainly from clinical trials, as well as from literature, post marketing studies and post marketing spontaneous reports to determine the event seriousness, expectedness, company causality, ensure complete and timely review aligning with internal and external reporting timelines.
- Analysis and assessment of SUSARs and important cases (designated medical events, AEs of special interest, etc
- Identify potential safety signals at single case level and escalating Product Lead Safety Physician/PV Scientist and Medical Monitors, and upper management as necessary.
- Maintain deep-knowledge of product labeling documentations (e.g., RSI, USPI, SmPC, etc) and provide input for labeling updates as required.
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