Drug Safety Officer

In Job S.p.A. – Milan's Career Center is hiring a

Drug Safety Officer

for a lead company in the pharmaceutical industry.

The Drug Safety Officer is directly responsible for establishing and maintaining harmonized and appropriate standards for the management of safety information within the global safety database.

KEY RESPONSIBILITIES

Manages collection of Individual Case Safety Reports (ICSRs) received from partners and affiliates;

Ensures processing of ICSRs in the safety database and interacts with affiliates and CROs/consultants to ensure quality of entered data;

Performs ICSRs download and submission of electronic reports through the EudraVigilance website;

Performs data reconciliation and compliance calculation activities with regard to ICSRs exchange with partners;

Reviews medical literature and contributes to keep screening strategies up-to-date;

Contributes to the maintenance and the update of safety database and PV tools configuration;

Contributes to generation and maintenance of SOPs, work instructions and policies relevant to the management of safety information.

JOB REQUIREMENTS

Bachelor's Degree in biological/medical sciences (e.g. Pharmacy, CTF, Biology or equivalent)

3+ years of relevant experience in pharmacovigilance or related field;

Excellent understanding of pharmacovigilance legislation and guidelines;

OFFERED FEATURES

12-month fixed-term contract with the possibility of extension

Work Schedule: from Monday to Friday.