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Safety Database Expert

ID:  780
Date of Posting:  Oct 4, 2024
Business Area:  Pharmacovigilance
Job Type:  Direct Employee
On site / Remote / Hybrid:  Hybrid
Location: 

Milano, IT

Territory: 
Full-Time or Part-Time:  Full Time
Seniority:  Entry level

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

Job Purpose

Support Pharmacovigilance Business Administrator (BA) & PVSystems Group coordinator for the maintenance and implementation of all the databases and tools used for the management of the PV activities.

The work can be performed partially as smart-working, as for Company policy.

Key Responsibilities

Responsible for the activities related to the implementation and maintenance of the databases (e.g., Oracle and Veeva Vault) and tools (e.g., Group SharePoint) used for the management of the PV activities. These include:

  • Databases/tools configuration, dictionaries (e.g., MedDRA and WHO), system updates according to the legislation;
  • Performing Data Transfer through ICSR import standard functionalities;
  • Data Migration relevant documents preparation;
  • Users support and training, interaction with the concerned internal departments, Affiliates and Providers;
  • Preparation of the validation documents and execution of validation tests, maintenance of documentation as required by SOPs/WIs and standards;
  • Preparation of the relevant SOPs and WIs;
  • Performance of testing and supporting the colleagues for the electronic transmission to Partners and Heath Authorities (e.g., EMA, FDA and other National Competent Authorities, as applicable);
  • EMA tools management (e.g., EVDAS) and concerned users’ support.

Required Education

A scientific degree and at least basic knowledge of pharmacovigilance requirements/obligations are required.

Required Skills and Experience

At least 2 years in similar role.

Technical Competencies

Good knowledge of safety databases and at least basic knowledge of SQL languages are required.

Required Behaviours and Competencies

Able to work in team and problem-solving skills.

Required Languages

Good knowledge (written and oral) of  English is required. Further knowledge of languages is well recognised.

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

Apply now »