Coordinate and compile data to complete a PSUR
Maintain open communication with Quality, Medical Operations, Clinical, Regulatory Affairs, and
Flag data collection/review delays to ensure on-time PSUR completion
Ensure compliance with Federal, State, local, and Company regulations

🎯 Requirements

Experience in medical writing or pharmacovigilance processes
Familiarity with PSUR and regulatory timelines
Strong cross-functional collaboration and written communication
Attention to detail and regulatory compliance knowledge
Bachelor’s degree or higher (education_required)
Ability to work in a global, matrixed environment

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