About this role
Join Cencora to process adverse event reports, perform signal detection, and prepare regulatory safety documents for pharmaceutical clients. This mid-level role involves ICSR processing, literature reviews, and risk management planning in the life sciences domain.
Must have
Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or related field
2+ years of experience in regulatory affairs, quality assurance, compliance, documentation control, or related field
Certification in regulatory affairs, quality management, compliance, or auditing preferred
Responsibilities
Recognize Adverse Event, Adverse Drug Reaction, and Medical Device Incident information from source documents
Process Individual Case Safety Reports per SOPs including triage, data entry, MedDRA coding, and narrative writing
Perform literature reviews as per applicable SOPs and work instructions
Prepare and review aggregate reports including PSURs, PBRERs, PADERs, and DSURs
Perform signal detection and prepare or update Risk Management Plans
Act as client contact point and work with internal and external stakeholders for information requests
Assist in audit preparation and file documents per applicable procedures
May be required to be on standby or on-call as part of this role
Benefits
Recruitment process
Full time position at Cencora, formerly AmerisourceBergen
Affiliated with Innomar Strategies
Role supports creation of healthier futures for people and animals
May require backup dependent care and caregiver leave support
