Jobsuche und Projektbörse
für Fach- und Führungs­kräfte

Ihre Online Jobbörse - jetzt den passenden Job finden

Bayern | Permanent employment with our customer | hays-searchresults-startdate | 402400/1
Preparation of submission documents for marketing authorization applications (MAA) requested by European authorities Supervision and provision of answers to outstanding authority questions during MAA Perform triage of incoming cases of Individual Case Safety Reports (ICSRs) and clinical trial serious adverse events, generates narratives including medical evaluation and generation of company comment Generate and ensure timely submission of Periodic Safety Update Reports (PSURs) Development Safety Update Reports (DSURs), Risk Management Plans (RMPs) and Signal Detection Reports On-going pharmacovigilance evaluation for medicinal products and creation of response documents for health authority requests Medical-scientific analysis of clinical trials, Post Authorisation Safety Studies (PASS) and non-interventional studies (NIS) concerning pharmacovigilance aspects Creation and maintenance of Standard Operating Procedures (SOPs) within Clinical Safety & Pharmacovigilance department Contribution to maintenance of pharmacovigilance quality management system Review of study synopses/protocols, investigators brochures, study reports and regulatory documents Contribution and support of Regulatory Affairs department concerning creation of regulatory documents