Jobsuche und Projektbörse
für Fach- und Führungs­kräfte

Hannover | Festanstellung durch unseren Kunden | Startdatum: sofort | 453361/1
Erstellung der periodischen Sicherheitsberichte, die Risikomanagementplanung sowie das Signalmanagement Entwicklung/Pflege der betrieblichen Referenzsicherheitsinformationen (RSI) in Zusammenarbeit mit der Regulatorischen Abteilung Beantwortung von Anfragen globaler Behörden Medizinische Beurteilung des Nutzenrisikos Analysen von Patientendaten einschließlich der wissenschaftlichen Literatur
Bavaria | Permanent employment with our customer | Startdatum: sofort | 452770/1
Part of the EU safety physician group at Clinical Safety and Pharmacovigilance department Establishing the strategy, direction, and priorities of pharmacovigilance activities Generate and ensure timely submission of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) On-going pharmacovigilance evaluation for medicinal products and creation of response documents for health authority requests Review of study synopses/protocols, investigators brochures, study reports and regulatory documents Medical-scientific analysis of clinical trials, Post Authorization Safety Studies (PASS) and non-interventional studies (NIS) concerning pharmacovigilance aspects Creation and maintenance of Standard Operating Procedures (SOPs) within Clinical Safety and Pharmacovigilance department Contribution and support of Regulatory Affairs department concerning creation of regulatory documents Responsibility for the medical review of aggregate regulatory documents, be accountable for safety surveillance, safety input and safety governance and risk management activities

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