Pharmaceutical Safety Expert
2 weeks ago
Lundbeck is a global biopharmaceutical company committed to improving the lives of people with neurological and psychiatric diseases.
Job DescriptionWe are seeking a Pharmaceutical Safety Expert to join our team. This role will be responsible for monitoring the safety profile of assigned Lundbeck products according to FDA and global regulatory Pharmacovigilance guidelines.
The incumbent will have a strong background in analysis of 'Big Data', with a good understanding of methodologies and leveraging real-world data to support and enhance PV activities.
This position requires a solid understanding of global PV regulations, maintaining oversight of safety-related post-approval commitments, risk minimization activities, and mandated REMS programs throughout the life cycle of assigned Lundbeck products.
The successful candidate will also be responsible for medical assessment of adverse events reported from post-marketing experience and clinical trials, detection and evaluation of safety signals, and risk management activities.
The responsibilities include contribution to the development of Global Medical Safety and cross-functional processes and procedures.
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