Related skills
data management regulatory affairs clinical operations pharmacovigilance medical writing๐ Description
- Coordinate and compile data to complete a PSUR.
- Maintain open communication with stakeholders during PSUR writing.
- Flag data collection delays and coordinate reviews to meet schedules.
- Ensure compliance with regulations, policies, and procedures.
๐ฏ Requirements
- PSUR writing and data coordination experience.
- Stakeholder communication across Quality/Medical Ops/Regulatory.
- Knowledge of federal/state/local regulatory requirements.
- Attention to timelines and on-time PSUR delivery.
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