Senior Safety Specialist

Senior Safety Specialist Overview

• The Senior Safety Specialist role is a remote, part-time contract position requiring expertise in pharmacovigilance and safety workflows.
• Contribute to the development of SOPs, Work Instructions, and supporting forms for safety standardization.
• Prepare project plans, training materials, and support ICSR processing for department infrastructure.
• Develop periodic reports such as Development Safety Update Reports (DSURs) and Investigator Brochure updates.
• Engage in signal detection, protocol development, and informed consent form updates for safety sections.
• Perform gap assessments, vendor strategy development, and oversight for compliance and governance.
• Configure safety databases, conduct user acceptance testing, and provide training and reconciliation report testing.
• Collaborate on pharmacovigilance activities, ensuring adherence to reporting requirements and clinical interfaces.
• This role offers flexibility and the opportunity to work with a dynamic team in a specialized field.

Senior Safety Specialist Key Responsibilities & Duties

• Develop and maintain SOPs, Work Instructions, and forms for safety standardization.
• Prepare project plans, training materials, and support ICSR processing activities.
• Create periodic reports, including DSURs, and update Investigator Brochures.
• Conduct signal detection and contribute to protocol and informed consent form development.
• Perform gap assessments and develop strategies for pharmacovigilance department organization.
• Oversee vendor contracts, SOP reviews, database configurations, and compliance metrics.
• Set up safety workflows and ensure adherence to international reporting requirements.
• Configure safety databases, conduct testing, and provide training for system users.
• Engage in ad hoc pharmacovigilance activities to address emerging needs.

Senior Safety Specialist Job Requirements

• Bachelor of Science (BS) degree in a relevant field is required.
• Minimum of 8 years of experience in pharmacovigilance or related safety roles.
• Preferred 10 years of experience in senior-level safety specialist positions.
• Proficiency in developing SOPs, Work Instructions, and periodic safety reports.
• Experience with signal detection, protocol development, and informed consent updates.
• Strong skills in vendor oversight, database configuration, and compliance monitoring.
• Ability to manage safety workflows and reporting requirements across international interfaces.
• Expertise in user acceptance testing and reconciliation report preparation.
• Flexibility to engage in ad hoc pharmacovigilance activities as required.