Senior Specialist Clinical Safety - Remote

Overview

The Senior Clinical Safety Specialist at Cencora will manage serious adverse events and ensure compliance with pharmacovigilance regulations to improve health outcomes.

In Short

• Manage Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs).
• Perform data entry and quality control for adverse event reports.
• Conduct MedDRA coding of adverse events.
• Report expedited cases using safety databases.
• Support the Clinical Safety Lead in developing Safety Management Plans.
• Write and submit Development Safety Update Reports (DSUR).
• Review pharmacovigilance regulations for clinical trials.
• Prepare for internal and external audits/inspections.
• Collaborate with various teams and take on additional responsibilities as needed.
• Contribute to a team-oriented and service-oriented environment.

Requirements

• Bachelor’s degree in medical, natural sciences, or pharmacy-related field.
• At least 1 year of relevant experience in pharmacovigilance.
• Knowledge of safety databases like Argus and Safety Easy.
• Experience in case management activities.
• Fluent in written and spoken English.
• Strong organizational and multitasking skills.
• High sense of responsibility and self-motivation.
• Ability to adapt to new and challenging situations.
• Excellent written and verbal communication skills.
• Team-oriented approach.

Benefits

• Competitive salary and benefits aligned with local market practices.
• Opportunities for professional growth and development.
• Supportive and inclusive work environment.
• Commitment to equal employment opportunities.
• Reasonable accommodations for individuals with disabilities.