Senior Specialist, Drug Safety
Core
Develop and maintain processes for high-quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations.
Role type
Senior Specialist, Drug Safety (Pharmacovigilance)
Builds
Compliant Individual Case Safety Report (ICSR) lifecycle processes and Global Safety Database configurations
Domain
Life Sciences / Pharmaceutical Regulatory Compliance
Required skills
Pharmacovigilance, Adverse Event Reporting, Regulatory Compliance, Auditing, Quality Control Management, Risk Management, Process Improvements, Data Analysis, Safety Management, Regulatory Inspections
Preferred skills
Clinical Risk Management, Regulatory Affairs
Technologies
Safety Systems, GCS&PV, Business Development Lifecycle Management System
Responsibilities
Lead development of PV processes with stakeholders; Perform safety system configuration and maintenance; Draft and maintain PV agreements and safety management plans; Perform quality review of expedited and periodic reports; Assist in preparing for Regulatory Agency Inspections and audits; Monitor group mailboxes for process inquiries.
Seniority
Senior, hands-on IC