Informationen zur Anzeige:
Local Safety Officer (m/w/d)
Cs2 ITEC GmbH & Co. KG
München (DE)
Aktualität: 11.12.2024
Anzeigeninhalt:
11.12.2024, Cs2 ITEC GmbH & Co. KG
München (DE)
Local Safety Officer (m/w/d)
Aufgaben:
- Cs2 ITEC bietet Ihnen als Berufseinsteiger oder erfahrenem Spezialisten ausgezeichnete Möglichkeiten der fachlichen und persönlichen Weiterentwicklung.
- Bei spannenden und abwechslungsreichen Tätigkeiten für internationale Großkunden und Konzerne, bauen Sie, je nach Aufgabenstellung und Position tiefes Fachwissen in neuesten Technologien oder breites Projektleitungs- bzw. Führungs-Know-how auf.
- Durch die Vielzahl unserer Themen können wir Ihnen, je nach persönlichen Wünschen, verschiedene Technologiebereiche und Aufgabenstellungen anbieten.
- Das bieten wir Ihnen:
- - Abwechslungsreiche Tätigkeiten in einem spannenden Aufgabenumfeld - Internationale Großprojekte bei namhaften Kunden - Mitarbeit in einem sympathischen und motiviertem Team - Angenehmes und kollegiales Arbeitsumfeld - Interessante Perspektiven für die fachliche und persönliche Weiterentwicklung - Attraktive Vergütung und flexible, familienfreundliche Arbeitszeiten
- Diese Aufgaben warten auf Sie:
- - Acts as the National Qualified Person for Pharmacovigilance or Local Safety Officer Contact Person in the country(ies) and with the Local Competent Authority(ies) - Provides 24/7 coverage for PV related matters (where required under regulation) and ensures that a local Business Continuity Process (BCP) for PV is in place - Performs timely monitoring of PV regulations in the assigned country(ies) and informs DSE CSPV of any regulatory changes and the potential impact to the PV system - Contributes to global process changes on project basis as needed.
- Facilitates the local implementation of global processes as required.
- Closely communicates with DSE CSPV (i.e.
- DSE EU PV Affiliate Management team) and contributes to the process improvement/enhancement at European level - Creates and updates local procedures in line with regulatory requirements and DSE CSPV processes - Performs oversight of PV vendor support for, or direct performance of, collection and recording of safety reports (any source) and notification of these reports to DSE as EU Headquarters.
- Translates any safety information, including Quality Checks, as required - Oversees any additional delegated activities performed by the vendor PV members and ensures a high standard and quality of delivered work - Performs reconciliation of safety information obtained through any potential source with appropriate internal and external stakeholders in a timely manner and in compliance with proceduress
- Was Sie mitbringen sollten:
- - Educational experience: Bachelor's degree in life science, pharmacy or medical sciences at minimum - Sufficient expertise in local, European and international regulatory and pharmacovigilance requirements - Fluent in the local language(s) of the assigned country and proficient in English - Experience engaging with Health Authorities - Considerable organisation awareness (interrelationship of departments, business priorities, including significant experience working cross-functionally) - Highly reliable with accurate operating principles - Analytic and systematic approach with good problem-solving skills - Ability to understand complex matters with a continuous focus on improvement - Strong communication skills, and ability to work in culturally diverse environment - Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams
- Wir freuen uns auf SIE !
- Cs2 ITEC GmbH & Co. KG Anton-Bruckner-Straße 2a 91052 Erlangen
Standorte
