Unlock New Career Opportunities: Safety Strategies
As a Senior Manager, Global Patient Safety, you will play a pivotal role in shaping safety strategies for molecules at various clinical development and post-marketing stages.
You will be responsible for aggregating and analyzing safety data to support informed interpretation and benefit-risk assessment. This will involve signal detection activities according to approved surveillance plans as well as the preparation and delivery of presentations at Signal Management Team meetings.
The ideal candidate must possess relevant risk management experience with FDA EU ICH guidelines regulatory bodies including pharmacovigilance medical case review database use prioritization self-discipline communication skills formal education above master's level,a typical day might look like this:
1. • Aggregate and analyze safety data to support informed decision-making
2. • Develop and implement effective safety strategies for molecules in clinical development and post-marketing phases
3. • Prepare and deliver presentations at Signal Management Team meetings on detected signals from available databases that have been analyzed using appropriate methodology
4. • Participate actively with cross-functional teams consisting of pharmacologists chemists biostatisticians clinicians researchers manufacturing operations quality assurance & Regulatory Affairs among others.
The primary responsibility is ensuring patient health while contributing significantly towards company business growth goals through scientific expertise knowledge sharing supporting project-specific needs which contribute positively.
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