Local Safety Officer (m/w/d)

Jetzt bewerben

Drucken

Cs2 ITEC GmbH & Co. KG

München (DE)

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

München (DE)

Passende Jobs zu Ihrer Suche ...

Local Safety Officer (m/w/d)