Senior Pharmacovigilance Scientist
hace 4 días
We are seeking a highly skilled Senior Pharmacovigilance Scientist to join our team at Neuraxpharm. As a key member of our Corporate PV department, you will play a crucial role in ensuring the safety of our medicinal products and compliance with regulatory requirements.
Your Mission:
As a Senior Pharmacovigilance Scientist, you will be responsible for supporting safety management activities for all Neuraxpharm products. This will involve carrying out PV activities in line with current local and global PV requirements, preparing and reviewing PV contracts, and coordinating the preparation and review of periodic safety reports and risk management plans.
Your Key Responsibilities:
- Support safety management activities for all Neuraxpharm products
- Carry out PV activities in line with current local and global PV requirements
- Prepare and review PV contracts
- Coordinate the preparation and review of periodic safety reports and risk management plans
- Monitor and oversee signal detection activities
- Organise, create, and implement risk minimisation measures, including PV educational materials
- Create standard operating procedures for the PV Department
- Ensure that PV activities for company-sponsored clinical trials are in line with company SOPs and applicable regulations
Requirements:
- At least 5 years of experience within the pharmacovigilance disciplines in the pharmaceutical industry
- Experience in PV related environments, preferably at local, regional, and global levels
- Experience in Local / Global safety regulations and standards (e.g., ICH, EU Regulation)
- Experience in Clinical Trial EU Regulation
- Knowledge of legislation in force concerning pharmacovigilance
- Advanced level management of MS Word, MS Excel, MS Access, and MS Outlook
- Bachelor or master's degree in life sciences (Degree in Pharmacy, Medicine, Biology, Chemistry or similar)
- Specific training in pharmacovigilance
- Fluent English
- Knowledge of other European languages (Spanish, German, French) will be valuable
Availability to Travel: 10%
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