Cluster Lead Local Safety Officer (LSO) CH/AT (m/f/x)

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Date: 21-Jun-2022

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

 

Passion for Innovation. Compassion for Patients.

 


Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

 

For our headquarter in Munich we are seeking highly qualified candidates to fill the position

 

Cluster Lead Local Safety Officer (LSO) CH/AT (m/f/x)


Roles and Responsibilities:

Activities as Local Safety Officer (LSO):

  • Ensures safety reports collection and follow-up process from any sources (including PTCs) in Switzerland and Austria (and possibly other countries) is implemented and oversees the processes are working properly. This includes the evaluation and update of local SOPs and local appendices to DSE affiliate core SOPs as required

  • Local contact person for Health authorities (NCPPV)

  • Acts as a primary contact person and leads preparation and CAPA management  for affiliate audits/inspections in designated countries

  • Performs/oversees local literature screening, monitoring of local PV legislation

  • Implementation of Risk Management Plans (RMPs) and additional Risk Minimization Measures as required, as well as local DHPC implementation

 

Activities as a multi-country Cluster Lead LSO:

  • Closely communicates with PV department at European headquarter (i.e. European PV Affiliate Management team) and contributes to the process improvement/enhancement at European level

  • Act as back-up for other cluster leads at European level

  • Manages and oversees local country-level LSO(s) and/or vendor LSOs in each country to fulfill the PV requirements in the assigned countries

 

Skills and additional Requirements:

  • Bachelor’s degree at minimum required; 5 years of experience with an advanced degree; 8 years of experience with a bachelor’s degree (Experience as Local Safety Officer is preferred.)

  • Master degree in Life Sciences, Pharmacy or Medical Sciences preferred

  • Strong knowledge of International, European and local PV laws and guidelines

  • Good or excellent written and verbal communication skills in English and German required, in addition good communication skills in French and/or Italian preferred

  • Analytic and systematic approach with good problem solving skills

  • Proactive, autonomous, accurate and reliable working style paired with the ability to work in international matrix teams

  • Ability to understand complex matters with a continuous focus on improvement

  • Substantial communication skills, in particular also on intercultural level with respect and appreciation of cultural diversity

What we offer


Working at Daiichi Sankyo

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.