JUNIOR PHARMACOVIGILANCE ASSOCIATE

Location

Siena (SI) | Italy

Job description

Job Title: JUNIOR PHARMACOVIGILANCE ASSOCIATE

Location: Siena - Italy

Department: Clinical

Junior Pharmacovigilance Associate

Philogen S.p.A. would like to hire a Junior Pharmacovigilance Associate. The role will report directly to the Responsible of Pharmacovigilance.

In particular the successful candidate will be responsible for:

• Collaboration in the assessment, triage and management of SAEs and SUSAR submission (e.g. CIOMS-I form preparation).
• Collaboration in the preparation and submission of the safety documents (e.g. DSUR and periodic safety reports) in accordance with applicable GCP requirements and legislation.
• Support in preparation of the Communication and Notification to the Competent Authorities and Ethics Committees.
• Assistant for the data coding using MedDRA dictionary.
• Writing of Standard Operation Procedures (SOP) related to the Pharmacovigilance area.
• Give support in preparation and in updating clinical documents including protocols, amendments, IB’s, interim and final safety reports to ensure regulatory compliance and safety throughout trial.
• Maintenance and archiving of the paper Trial Master File in collaboration with the CTA.
• Revision of clinical listings to clean safety data in collaboration with medical manager, CRA and data manager.
• Support in pharmacovigilance post-marketing activities.

The ideal candidate should have:

• Scientific background
• Previous experience in Pharmacovigilance activities or a Master degree in Pharmacovigilance.
• Excellent written, verbal and organizational skills.
• Strong prioritization skills.
• Ability to handle multiple projects and stressful situations.
• Good skills in data analysis.
• Excellent scientific writing skills and fluency of the English language.

We offer:

A contract and salary proportional to the experience (seniority) of the successful candidate.

Job location:

Siena – Italy

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address [email protected], specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

Job tags

Salary