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Safety Officer
il y a 1 mois
Daiichi Sankyo Europe is a leading pharmaceutical company with a strong commitment to pharmacovigilance and regulatory compliance. We are seeking a highly skilled Pharmacovigilance Expert to join our team in France.
The successful candidate will be responsible for ensuring compliance with relevant pharmacovigilance regulatory requirements globally and locally, overseeing the local pharmacovigilance system, and executing operational tasks. The individual will also manage local stakeholders and vendors, and provide PV Training to relevant local functions and external parties.
Key Responsibilities:
- Ensure safety reports collection process in the designated countries is implemented and oversees the processes are working properly.
- Evaluate and update local SOPs and local appendices to DSE affiliate core SOPs as required.
- Perform/oversee monitoring of local PV legislation and implementation of Risk Management Plans (RMPs) and additional Risk Minimisation Measures as required.
- Be accountable for managing local stakeholders (e.g. Marketing) as well as local PV vendors.
- Providing PV Training to relevant local functions and external parties as necessary to ensure PV processes are implemented properly.
Requirements:
- Previous experience of Pharmacovigilance activity in a France affiliate.
- Bachelor's degree in Life Sciences, Pharmacy or Medical Sciences with post graduate qualification preferred.
- Possesses strong knowledge of International, European and local PV laws and guidance.
- A focus on accuracy and integrity.
- Analytic and systematic approach with good problem-solving skills.
- Ability to understand complex matters with a continuous focus on improvement.
- Strong communication skills and an ability to work with respect and appreciation of cultural diversity.
- Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams.
- Flexible and adaptable.
Why work with us?
Working at Daiichi Sankyo Europe is more than just a job - it's an opportunity to make a difference and change the lives of patients for the better. We can only achieve this ambitious goal together. That's why we encourage a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you'll have the chance to develop, think boldly, and bring your ideas to the table. If you have a proactive mindset and a passion for responding to patient needs, we're eagerly awaiting your application.
