Job Title:
Aggregate Report PV Scientist
Description:
Proclinical is seeking a skilled Aggregate Report PV Scientist to oversee the creation and management of various reports. As a subject matter expert on global safety requirements, this individual will collaborate with vendors and quality management teams to ensure compliance with global pharmacovigilance regulations.
Please note that candidates must have the right to work in the location or hold an EU passport to be considered for this role.
Responsibilities:
1. Collaborate with the PV Scientist Lead to author safety reports.
2. Provide expert knowledge on safety requirements and pharmacovigilance activities.
3. Spearhead process improvements for consistency in reporting and safety oversight.
4. Maintain the Reports Master Schedule and stay up-to-date on worldwide legislation updates.
5. Coordinate and author responses to regulatory safety questions.
6. Contribute to initiatives for process improvement and consistency in safety reporting.
Key Skills and Requirements:
1. Ability to interpret and present scientific and medical data effectively.
2. A team player with experience in safety, clinical development, and regulatory environments.
3. Experience managing and authoring aggregate data reports.
4. Familiarity with pharmacovigilance, drug development, and safety regulations.
5. Strong organizational skills and ability to prioritize tasks independently.
6. Proficiency in data processing software (Excel, PowerPoint, Word) and safety database systems.
7. Bachelor's degree in biological or natural sciences; advanced degree preferred.