Junior Pharmacovigilance Officer
Milano, IT
Job Purpose
We are looking for a Junior Pharmacovigilance Officer to perform an effective and compliant ICSRs management.
Key Responsibilities
Managing the Individual Case Safety Report (ICSR) in agreement with the enforced legislation, PVAs and the Company SOPs/WIs:
- Performing the common email box triage
- Performing the case assessment (e.g. seriousness and expectedness/listedness)
- Performing the follow up requests
- Submitting the ICSRs to the relevant Competent Authorities
- Distributing the ICSRs to the concerned Contractual Partners as per PVAs
- Performing the monthly ICSRs reconciliation with Contractual Partners
- Performing quality check of the activities performed by Service provider
- Performing the case Data Entry and Quality Control, as deemed necessary
Required Education
A scientific degree and at least basic knowledge of pharmacovigilance requirements/obligations are required.
Required Skills and Experience
At least 6 months in a similar role
Good knowledge of GVP
Able to work in a team and problem-solving skills.
Required Behaviours and Competencies
Required Languages
Good knowledge (written and oral) of the English language is required. Further knowledge of languages is a plus.