Regulatory Specialist/PV Officer - Safety Reporting

Job Description

Assurance and exertion of activities leading to effective cooperation with clients in the area of safety reporting

Support the client in all aspects of safety reporting

Performing submissions of ICSRs/aggregate reports to all concerned partiesPerforming exchanges of ICSRs with all concerned parties as per applicable quality documentsPerforming XEVMPD maintenance Supporting the client with EudraVigilance registration and maintenance of EudraVigilance accountSupport in all PV operations associated with Safety ReportingQuality control of daily safety reporting activitiesActive participation in trainings, maintenance and development of quality system documents for Safety Reporting areaMore senior colleague may perform tasks assigned as per SOP to more junior position

Qualifications

Life science graduate, pharmacy, nursing or minimum 2 years of experience inSafety Reporting area

2-5 years of work experience in pharmacovigilance

Organization skills, including attention to detail and multitasking

Management skills, including time and issue management Communication skills Presentation skillsAbility to motivate/coach people; leadership

English - advanced (spoken, written)

Additional Information

• Competitive salary
• Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
• Friendly working environment with several social events per year