Proclinical seeks an Aggregate Report PV Scientist to manage reports and ensure compliance with global pharmacovigilance regulations.
Key Responsibilities:
* Author safety reports in collaboration with the PV Scientist Lead.
* Provide expert knowledge on safety requirements and pharmacovigilance activities.
* Support process improvements for consistency in reporting and safety oversight.
* Maintain the Reports Master Schedule and oversee worldwide legislation updates.
* Coordinate and author responses to regulatory safety questions.
* Contribute to initiatives for process improvement and consistency in safety reporting.
Essential Skills and Requirements:
* Ability to interpret and present scientific data clearly.
* Collaborative team player with experience in safety, clinical development, and regulatory environments.
* Experience in managing and authoring aggregate data reports.
* Familiarity with pharmacovigilance, drug development, and safety regulations.
* Strong organizational skills and ability to prioritize tasks independently.
* Proficiency in data processing software (Excel, PowerPoint, Word) and safety database systems.
* Bachelor's degree in biological or natural sciences; advanced degree preferred.