Sanja E. Email & Phone Number

Croatia

Zagreb, Croatia

• Acting as key liaison between company and client• Ensuring all project deliverables meet client's expectations, including accurate projections, reports, updates and risk assessments• Overseeing, and and being accountable for all project deliverables including KOM, QSC, day to day operational management and execution of deliverables, financial performance and budget• Developing project specific SMPs• Ensuring projects meet KPIs• Preparing overall SPVG strategy and status at client meetings• Budgeting, planning resources, resolving backlog• Ensuring document compliance of quality deliverables• Training the project team• Participating in bidding proposals

Zagreb

• Managing ongoing projects and setting up new projects• Maintaining good client relations and ensuring consistent high quality work• Organising/chairing/attending regular monthly client meetings• Advising the client in PV matters• Providing the client with appropriate qualified resources• Ensuring/managing compliant processing and reporting according to worldwide PV regulatory obligations • Participation in client audits and inspections• Manage root cause analysis and CAPA implementation process• Managing the process for drug safety updates or reviews • Overview of case workflow management

Zagreb

• management of client projects under the supervision of Project Manager• client communication, ensuring timelines on processing and reporting are met• FTE estimation and forecast• ICSR QC• workflow management• new starter training• line management including quality compliance tracking, feedback, holding appraisals• LCPPV activities including overview of local literature and regulatory screening, local regulatory authority communication, providing monthly reports and performing periodic ICSR reconciliations

Zagreb

• processing post marketing, literature and clinical study Individual Case Safety Reports (ICSRs) in English and German• ICSR reconciliations with business partners• assisting with pharmacovigilance processes including controlled document, and audit preparation

Zagreb, Croatia

• validating laboratory findings• quality control• calibration• verification• meeting accreditation requirements ISO 15189Biochemistry:• Roche Cobas c311, Abbott cArchitect 4000Immunochemistry:• Roche Elecys 2010, Abbott Architect i2000Hematology• Abbott Ruby• blood smear differentiation microscopy• Samson LIS interface• Expert meetings at KBCSM - held presentation "Calibration reports"

Master, Mag. Med. Biochem., Clinical/Medical Laboratory Science/Research And Allied Professions, Very Good

Thesis title: "Paraoxonase 1 activity and the concentration of thiol groups in gynecological carcinomas"

Highschool Diploma, Linguistic Gimnasium, Excellent

Activities and Societies: DSD classes.