Sr Associate Global Safety
Core
Conduct core safety activities including data collection, processing, distribution, and regulatory submission of adverse events and periodic safety reports within the local country to support Amgen Global Patient Safety and the local business.
Role type
Associate Global Safety (Pharmacovigilance)
Builds
Adverse event reports, periodic safety reports, and safety communications for local regulatory authorities
Domain
Life Sciences / Pharmacovigilance
Required skills
Adverse event reporting, regulatory submission, safety database management, local legislation compliance, CAPA resolution, safety screening, risk minimization implementation
Preferred skills
Healthcare professional qualification (doctor, pharmacist, nurse, vet), doctoral degree, biotech/pharma industry experience, clinically based or regulatory agency role
Technologies
Safety databases, GRAAS SOPs, local regulatory reporting systems
Responsibilities
Capture, route, translate, and follow up adverse events reported in the local country; Assist with timely submission of all reportable adverse event reports; Assist with distribution of periodic safety reports; Assist in safety screening of local medical literature; Participate in resolution of local issues through CAPAs; Represent as point of contact for Health Authority Inspection and Internal Process Audits; Escalate product safety issues to local Safety Manager; Assist in providing product safety training to commercial or medical colleagues.
Seniority
Associate, operational execution