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Medical Safety Officer (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
REFERENZNUMMER:
316465/11
IHRE AUFGABEN:
-Manage and oversee medical safety for all assigned assessment studies within the assessment program for one or more risk reduce products spanning across multiple functions and pillars of the risk reduce products assessment program (e.g., clinical studies, perception and behavioural studies) pre- and post-market launch
-Actively support medical safety surveillance activities occurring pre- and post-market
-Serve as a technical leader and a key resource to client's management and provide medical safety expertise in medical safety
-Establish the requirements, processes and plans related to safety monitoring and safety signal detection as well as the assessment, processing, communication and appropriate documentation of individual safety cases and aggregated analysis
-Seamless integration with multiple sub-functions in R&D (product testing, product development and NGP programs) and relevant client's functions (market research, brand building, operations, law and corporate affairs)
IHRE QUALIFIKATIONEN:
-Physician with medical doctor diploma (MD board certification). A degree in a medical/pharmacology specialty an asset (such as pharmaceutical medicine, clinical pharmacology, internal medicine, cardiology, physiology, pneumology, pharmacovigilance
-Profound experience in medical safety acquired in industry, CRO and academia
-Knowledge of safety methods, processes, assessment and reporting used in the area of the scientific/clinical/medical aspects in clinical studies
-Experience gained in pharmaceutical medicine, pharmacovigilance, clinical pharmacology, pharmacokinetics, nicotine replacement therapy/smoking cessation
-Good knowledge of ICH CGP (track record of GCP trainings), pharmacovigilance related guidelines and rules in US, EU and JP
-Fluency in English
WEITERE QUALIFIKATIONEN:
Drug safety manager
316465/11
IHRE AUFGABEN:
-Manage and oversee medical safety for all assigned assessment studies within the assessment program for one or more risk reduce products spanning across multiple functions and pillars of the risk reduce products assessment program (e.g., clinical studies, perception and behavioural studies) pre- and post-market launch
-Actively support medical safety surveillance activities occurring pre- and post-market
-Serve as a technical leader and a key resource to client's management and provide medical safety expertise in medical safety
-Establish the requirements, processes and plans related to safety monitoring and safety signal detection as well as the assessment, processing, communication and appropriate documentation of individual safety cases and aggregated analysis
-Seamless integration with multiple sub-functions in R&D (product testing, product development and NGP programs) and relevant client's functions (market research, brand building, operations, law and corporate affairs)
IHRE QUALIFIKATIONEN:
-Physician with medical doctor diploma (MD board certification). A degree in a medical/pharmacology specialty an asset (such as pharmaceutical medicine, clinical pharmacology, internal medicine, cardiology, physiology, pneumology, pharmacovigilance
-Profound experience in medical safety acquired in industry, CRO and academia
-Knowledge of safety methods, processes, assessment and reporting used in the area of the scientific/clinical/medical aspects in clinical studies
-Experience gained in pharmaceutical medicine, pharmacovigilance, clinical pharmacology, pharmacokinetics, nicotine replacement therapy/smoking cessation
-Good knowledge of ICH CGP (track record of GCP trainings), pharmacovigilance related guidelines and rules in US, EU and JP
-Fluency in English
WEITERE QUALIFIKATIONEN:
Drug safety manager
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Sonstiges