Safety Associate [F/M/X]

at  Amaris

Job description
Job Purpose: We are seeking a dedicated Safety Physician to actively manage and evaluate risks associated with assigned vaccine projects. The successful candidate will work closely with the Safety Scientist to coordinate medical analyses of adverse event reports and support signal detection activities.

Conduct medical analysis of adverse event reports and signal detection for assigned vaccine projects in clinical development and post-licensure.
Serve as the safety contact for Clinical, Regulatory Affairs, regional, and local safety managers.
Provide medical input on safety aspects in the design and preparation of clinical protocols, investigator brochures, and reports.
Conduct Benefit-Risk Assessments and manage risk identification, assessment, and mitigation for vaccine projects.
Lead the Safety Review Team and participate as a member of the Vaccine Leadership Team (VLT) for assigned projects.
Develop and revise pharmacovigilance processes and training materials.
Respond to inquiries from regulatory authorities regarding safety aspects of the projects.
Ensure compliance with applicable regulations and participate in safety-related interactions with external collaborators.