Review and approve post-marketing Individual Case Safety Reports and Serious Adverse Event reports for medical assessment, including coding and causality.
Support signal detection activities, review aggregate reports like PBRERs and DSURs, and provide input for Risk Management Plans and regulatory responses.
Utilize advanced English and Japanese language skills to collaborate cross-culturally with global teams and clients, ensuring high-quality pharmacovigilance services.
PrimeVigilance is a specialized pharmacovigilance service provider offering support in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance to pharmaceutical and biotechnology partners globally. It is a mid-size company that values employee training, well-being, and a healthy work-life balance, fostering a collaborative, human-centric environment with team members across continents.
Monitors all safety aspects of clinical research trials.
Collects, assesses and processes Adverse Events (SAE) for safety reporting.
Prepares narratives of adverse events for adjudication by the CEC.
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. At Cordis, teammates bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives.
Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
Provide internal teams and Clients with expertise and guidance on national requirements.
Ergomed Group is a rapidly expanding global full-service mid-sized CRO specializing in Oncology and Rare Disease. The company includes the more specialised brands- PrimeVigilance, Adamas Consulting and Ergomed CRO and values employee experience, well-being and mental health.