Activity Manager 196

Specific activities and responsibilities:

• Responsible for the Quality review/inputs of vigilance cases (as required)
• Medical evaluation of the cases (as required)
• Pre-analysis and support the team for complex cases
• Challenge and improve the client process and system
• Training the team as per the client conventions/ SOPs/ EMA guidelines
• Support in NC and CAPA for case processing
• Support and participate in audit and inspections
• Good understanding of EU GVP and ICH requirements
• Lead and manage big projects
• Support the Case management Director for technical inputs and solutions

Required education:

Pharmacist, life science graduate, Medical doctor

Required experience:

PV experience of more than 5 years

Required languages: (other than English)

French (Native / Bilingual Proficiency)

Required technical skills:

• Managerial skills
• Teamwork and team handling capacity
• Communication with the client
• Flexibility
• Process orientated
• Organisation

Additional experience and/or skills:

Database experience preferred (e.g., Argus, ArisG, lifespeares, AB Cube Database).