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).

Activity Manager 196