Berater Pharmakovigilanz
Schlagwörter
Skills
Senior pharmacovigilance consultant offering strategic advice on PV systems and processes, as well as efficient, high quality, hands-on support with your PV data collation, analysis, assessment and reporting needs. Building on over 20 years of experience, we offer a broad range of services including:
• Pharmacovigilance systems and processes: Consulting, audit, gap analysis and optimisation
• Signals and assessment: Medico-scientific evaluation of your safety data, literature reviews and comprehensive signal evaluation
• Periodic safety reports: Authorship of PSURs, PBRERs, DSURs, PADERs etc.
• Risk management plans: Planning and authorship of EU- and non-EU RMPs for regulatory submission
• Safety-related communications: Authorship and maintenance of CCDS/CCSIs, SmPCs, IBs/RSIs etc.
• Training: On-site staff training in pharmacovigilance, risk management and pharmacoepidemiology.
Based in southwest Germany, we offer our services across Europe. We will work with you to identify the deliverables that best meet your requirements.
• Pharmacovigilance systems and processes: Consulting, audit, gap analysis and optimisation
• Signals and assessment: Medico-scientific evaluation of your safety data, literature reviews and comprehensive signal evaluation
• Periodic safety reports: Authorship of PSURs, PBRERs, DSURs, PADERs etc.
• Risk management plans: Planning and authorship of EU- and non-EU RMPs for regulatory submission
• Safety-related communications: Authorship and maintenance of CCDS/CCSIs, SmPCs, IBs/RSIs etc.
• Training: On-site staff training in pharmacovigilance, risk management and pharmacoepidemiology.
Based in southwest Germany, we offer our services across Europe. We will work with you to identify the deliverables that best meet your requirements.
Projekthistorie
05/2007
-
bis jetzt
Senior pharmacovigilance consultant offering strategic advice on PV systems and processes, as well as efficient, high quality, hands-on support with your PV data collation, analysis, assessment and reporting needs. Building on over 20 years of experience, we offer a broad range of services including:
• Pharmacovigilance systems and processes: Consulting, audit, gap analysis and optimisation
• Signals and assessment: Medico-scientific evaluation of your safety data, literature reviews and comprehensive signal evaluation
• Periodic safety reports: Authorship of PSURs, PBRERs, DSURs and PADERs
• Risk management plans: Planning and authorship of RMPs for regulatory submission
• Safety-related communications: Authorship and maintenance of RSI/CCDS/CCSIs, SmPCs, IBs
• Training: On-site staff training in pharmacovigilance, risk management and pharmacoepidemiology.
Based in southwest Germany, we offer our services to pharmaceutical companies across Europe. We will work with you to identify the deliverables that best meet your needs.
• Pharmacovigilance systems and processes: Consulting, audit, gap analysis and optimisation
• Signals and assessment: Medico-scientific evaluation of your safety data, literature reviews and comprehensive signal evaluation
• Periodic safety reports: Authorship of PSURs, PBRERs, DSURs and PADERs
• Risk management plans: Planning and authorship of RMPs for regulatory submission
• Safety-related communications: Authorship and maintenance of RSI/CCDS/CCSIs, SmPCs, IBs
• Training: On-site staff training in pharmacovigilance, risk management and pharmacoepidemiology.
Based in southwest Germany, we offer our services to pharmaceutical companies across Europe. We will work with you to identify the deliverables that best meet your needs.
Reisebereitschaft
Weltweit verfügbar
exali consult-Haftpflicht-Siegel
Das original exali consult-Haftpflicht-Siegel bestätigt dem Auftraggeber, dass die betreffende Person oder Firma eine aktuell gültige branchenspezifische Berufs- bzw. Betriebshaftpflichtversicherung abgeschlossen hat.
Versicherungsbeginn:
05.04.2019
Versicherungsende:
01.05.2024
