- Identification and transmission of Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Identification and transmission of spontaneous reports of adverse reactions through the Argus system.
- Collection and management of reports from healthcare professionals, patients, or through Scientific Representatives.
- Collection of the follow-up information necessary for the completeness of a spontaneous report of suspected adverse reaction.
- Collection and management of adverse events from clinical trials and follow-up.
- Management of periodic safety communications to health authorities
- Degree in scientific subjects with a pharmaceutical or biomedical specialization (i.e., CTF, pharmacy, biology, biotechnology, etc.)
- English: full professional knowledge
- Pharmacovigilance Specialization (nice to have)
- Excellent oral and written communication skills
- Strong interpersonal skills and a knack for productive collaboration across varying departments
- Detail-oriented and data-driven
- Possess an encouraging, can-do attitude
- Strong motivation
Pharmacovigilance Internship - Sesto Fiorentino, Italia - Lilly
Descrizione
We're looking for people who are determined to make life better for people around the world.
Objective
Pharmacovigilance is a department of Medical Affairs focused on detecting, assessing, understanding, and preventing the adverse effects of medications.
The successful candidate wil receive an intensive training on the Italian and European legislation on Pharmacovigilance in clinical trials and in the post-registration phase as well as on the main company Standard Operating Procedures (SOPs) in the field of Pharmacovigilance. Will learn how to manage the case safety reports, working with the safety management systems (Argus) for case entry (initial and follow-up) and expedited reporting and will also collaborate with the team in managing all the task relevant for the pharmacovigilance area.
The final objective is experiencing the diverse PHV topics being trained on the main processes.
Activities
The successful candidate will interact closely with Pharmacovigilance (PhV) team and several different Company functions supporting the following activities:
Requirements
Personal traits
Project results and major learning opportunity
At the end of the project the lead candidate will acquire all the capabilities and knowledge relevant for Pharmacovigilance associate with specific focus on case management, periodic reporting, knowledge of the company PhV System as well as a broad overview of the Company structure interacting with different functions and depertiments.
Internal relationship
The lead candidate will work closely with the PhV team and Director at local as well as at international level with several different Company Departiments
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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