Role – Senior Manager Pharmacovigilance
Location – Budapest, Hungary
Rate – Competitive
Type – Perm
An opportunity an arisen for talented Pharmacovigilance Manager to join a rapidly growing CRO on a permanent basis. With great scope for career progression this is an opportunity you dare not miss out on. In this role you will manage and direct the company’s pharmacovigilance projects, whilst developing and maintaining the necessary processes to ensure high quality.
- Develop processes and SOPs to ensure all safety information is collected and process in accordance with FDA, EMA and ICH requirements
- Oversight of day to day safety monitoring activities and safety operations for all investigational and marketed products
- Manage Adverse Events reporting and develop case report
- Author and/or review for periodic safety regulatory documents according to the agreed process and timelines.
- Manage and maintain safety database
- QPPV qualifications is a plus, but not mandatory
- Relevant degree, preferably in life science.
- At least 5 years of direct pharmacovigilance work experience in pharma or CRO
- Working knowledge of relevant FDA, EMA and ICH guidelines, initiatives, and regulations and a comprehensive understanding of Global Pharmacovigilance regulatory obligations
- Working knowledge of MedDRA, WhoDrug Global, INH-CTCAE
Apply now for immediate consideration or contact Michael Owusu-Ansah on +44 203 928 6631
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Agency providing Global Staffing services.