Pharmacovigilance Specialist

MANTU GROUP SA; Milano; Remoto; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A global technology consulting firm based in Milan is seeking a Pharmacovigilance Specialist to support ICSR case processing in a dynamic environment. The ideal candidate will have 2-3 years of experience in Pharmacovigilance, including data entry, case validation, and quality checks. Fluency in English and knowledge of Italian are required. This role offers the flexibility to work fully remotely and be part of an international community.

Servizi

Robust training system

Vibrant workplace with internal events

Strong commitments to CSR

Fully remote work policy

Competenze

• 2–3 years of experience in Pharmacovigilance.
• Experience in data entry and case validation.
• Understanding of GVP Modules relevant to case processing.
• Strong documentation skills and accuracy.

Mansioni

• Support end-to-end ICSR case processing activities.
• Perform quality checks of ICSR data.
• Maintain accurate documentation of case processing activities.

Conoscenze

Pharmacovigilance

Data entry

Case validation

Quality checking

English proficiency

Italian knowledge

Formazione

Life Sciences

Pharmacy

Medicine

Strumenti

Argus Safety Database

Descrizione del lavoro

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Recruitment Process

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 – the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!

Job description

Join our team as Pharmacovigilance Specialist (remote). Start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast‑growing organization. Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in an industrial field, but above all, being an ambassador of our organization to clients, thanks to: Your interpersonal skills and ability to listen, in order to build a strong relationship of trust with our clients and fully understand their challenges and issues. Your curiosity and eagerness to learn, as we support over 1,000 clients from all sectors worldwide.

Your missions

• Support end‑to‑end ICSR case processing activities for established products and rare disease portfolios
• Perform data entry of adverse events in compliance with regulatory requirements
• Conduct case validation and ensure accuracy of collected information
• Perform quality checks of ICSR data, ensuring narrative and medical coding consistency
• Distribute cases to commercial partners and regulatory authorities (EMA, MHRA, FDA) in a timely manner
• Manage follow‑up activities for ongoing cases
• Ensure compliance with global safety reporting workflows and timelines
• Maintain accurate and thorough documentation of all case processing activities

Your profile

• Experience: 2–3 years in Pharmacovigilance with solid exposure to ICSR case processing
• Experience in data entry, case validation, and follow‑up management
• Experience in quality checking ICSR data and ensuring narrative/medical coding consistency
• Experience in distributing cases to commercial partners and, ideally, regulatory authorities (EMA, MHRA, FDA)
• Experience with Argus Safety Database is preferred
• Understanding of GVP Modules relevant to case processing
• Knowledge of global safety reporting workflows and compliance requirements
• Academic background: Life Sciences, Pharmacy, Medicine, or related field
• Fluent English for global communication and safety documentation. Good knowledge of Italian language.
• Accuracy, attention to detail, and strong documentation skills
• Ability to work with minimal supervision while maintaining high‑quality deliverables

What we offer

• An international community, bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• Strong commitments to CSR, notably through participation in our WeCare Together program
• Remote policy: Possibility to work fully remotely

Diversity and inclusion

Amaris Consulting is proud to be an equal‑opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.