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Senior Safety Reporting Specialist
vor 1 Woche
Job Summary
The Aggregate Reports PV Scientist plays a crucial role in managing processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports), acting as the Subject Matter Expert. This position requires strong project management skills and collaboration with the PV Scientist Lead.
Key Responsibilities
- Manage and author aggregate safety reports such as PSURs, DSURs, PADERs, and local reports in collaboration with the PV Scientist Lead.
- Serve as the SME on relevant safety requirements, company policies/procedures related to pharmacovigilance activities and aggregate reports knowledge.
- Support process improvement by implementing and maintaining processes.
- Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview (production, update, stakeholders review).
- Collaborate with the PV Scientist Lead to coordinate and author responses to safety questions from regulatory authorities.
- Contribute to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management, and responding to ad hoc safety questions.
Requirements
- Master's degree or degree in Life Sciences or related field.
- 8+ years of work experience in PV, including strong focus on authoring aggregate reports (min. 2 years).
- Strong pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations.
- Ability to collaborate in a team, cross-functional (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
- Represent and speak to processes in cross-Safety and cross-functional forums.
- Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations.
- Knowledge of common data processing software as well as common safety database systems.
- Strong communication skills in English and organizational skills.
