Description
My client is a biopharmaceutical company which is active worldwide. At their site in Switzerland they employ about 1'300 people to develop and produce therapeutics from human plasma for international markets.For their Intercontinental Commercial Operations Organization I am seeking an experienced
Regional Safety & Quality Officer EEMEA
The position is the primary pharmacovigilance and quality coordination interface between distributors and agents in Middle East, Africa and CIS region and the quality and safety departments across the company. It is responsible for pharmacovigilance (PhV), clinical safety and quality coordination to ensure compliance with relevant policies, procedures and local regulations.
Your main tasks will be:
- Coordination of the establishment of the drug safety and quality framework (i.e. agreements, processes, trainings) between the company and its third party distributors in EEMEA
- Coordination of the development of the PhV policy framework within EEMEA to meet and retain increasing regulatory requirements
- Ensuring the timely and bidirectional communication of emerging or critical safety issues involving licensed and investigational products and supporting third parties with the implementation of local processes
- Establishment of formal PhV training modules for internal staff (ICO head office + all EEMEA staff) and the EEMEA business partners
- Participation in PhV and Quality audits and assist as appropriate, coordination of audit preparation internally and with external partners, coordination of the development of the CAPA plans and tracks implementation of corrective actions
- Degree as MD, VetD, PharmD or PhD in biology or biochemistry
- Professional experience in pharmacovigilance in a multinational innovative pharmaceutical company
- Good understanding of pharmaceutical quality management systems (GMP, GVP, GCP, GLP)and regulations
- Languages: Proficiency in English,additional languages German, French, Arabic or a Slavic language are an asset
- Customer focus by establishing and maintaining effective relationship
- Strong analytical skills and ability to structure complex issues
- Ability to work under pressure and to prioritize and delegate appropriately to meet deadlines and qualitative objectives
What they offer:They offer the opportunity to get an insight in a global specialty pharmaceutical company,attractive salary and much more. The next step is yours.
I am looking forward to receiving your online application on or for more informations you can reach me on