Job description:

• Creation and update of new SOPs, according to legislation updates and process improvements, ensure implementation of projects across departments;
• Ensure implementation of CAPAs;
• Safety Data Exchange Agreements (SDEAs): negotiation of SDEAs, informing/ training relevant stakeholders on their responsibilities as per SDEA;
• Due diligence process: legacy data assessment, transfer, timelines;
• Integration process: integrate the PV system of newly acquired companies into Alvogen’s.

Requirements:

• English language: advance level (both speaking and writing, good undestanding of medical English terms is a must)
• Computer skills: very good knowledge of MS Office tools (MS Excel knowledge is a must)
• Communication skills: highly flexible individual with very good communication skills which can enable system improvement
• Knowledge of EU pharmacovigilance regulations is a must
• Other regions PV regulations knowledge is a plus
• Previous experience in processing ICSRs, PSURs and RMPs is a must
• Enthusiastic
• Proactive
• Team player and also able to perform alone (depending on the project)
• Open minded and willing to take over new responsabilities if needed