Job overview :
Provides data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and marketed product safety activities.
Triages, tracks, and processes safety data; assesses safety data for report-ability to the client safety department or relevant regulatory bodies;
maintains communication (phone, fax, email) with investigative sites or marketed product reporters to obtain accurate data regarding safety events;
and contributes to lifecycle safety deliverables
Analyzing in-process quality checks, reporting of results, tracking quality findings, metrics against, defined KPIs
Analyzing quality deviations, identifying root causes, adjudicating ICSR corrections with corresponding issuance of CAPA, as appropriate, to evaluate CAPA effectiveness
Driving continuous process improvement for Case Management by partnering with all entities, Country Safety Leads, License Partners, and vendors
overseeing CAPA management for Case Management
managing vendor quality activities, identifies opportunities for improvement; managing Case Management compliance
overseeing the in-process workflow of all ICSRs and implementing strategies to prevent late ICSR reports
serving as a SME during internal / partner audits and Health Authority inspections in this role
Bachelor's Degree Minimum of three years of experience in international pharmacovigilance area; certified degree in a Health Science area (Pharmacist, PharmD, Registered Nurse) or a minimum of 5 years of experience in ICSR management.
Working knowledge of global pharmacovigilance regulations strong knowledge of medical terminology excellent communication
kills computer literacy, use of MS Office (e.g. Word, Excel, ect.)
must have excellent oral and written skills in English