Senior Pharmacovigilance Specialist

Amaris Consulting; Milano; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global technology consulting firm is seeking a Senior Pharmacovigilance Specialist to support case processing activities and ensure compliance with safety reporting workflows. The ideal candidate will have at least 6 years of experience in Pharmacovigilance, strong attention to detail, and familiarity with regulatory authorities such as EMA and FDA. This role offers the possibility of remote work and is ideal for mid-senior level professionals.

Servizi

Robust training system through internal Academy

Vibrant workplace with events

Strong commitment to CSR

Competenze

• At least 6 years of experience in Pharmacovigilance.
• Solid exposure to ICSR case processing.
• Experience distributing cases to regulatory authorities.

Mansioni

• Support end-to-end ICSR case processing activities.
• Perform data entry of adverse events in compliance with regulations.
• Conduct case validation and ensure accuracy of information.
• Perform quality checks of ICSR data for consistency.

Conoscenze

Pharmacovigilance experience

Data entry

Case validation

Quality checking ICSR data

Understanding of GVP Modules

Fluent in English

Good knowledge of Italian

Attention to detail

Formazione

Degree in Life Sciences, Pharmacy, or Medicine

Strumenti

Argus Safety Database

Descrizione del lavoro

Join to apply for the Senior Pharmacovigilance Specialist role at Amaris Consulting.

Amaris Consulting is an independent technology consulting firm with over 1,000 clients worldwide, delivering solutions across Information System & Digital, Telecom, Life Sciences, and Engineering. Our international team of 7,600 professionals spans 5 continents and more than 60 countries.

We focus on building a top talent community where every team member can reach their full potential. Our culture emphasizes integrity, trust, and continuous learning.

Recruitment Process

• Brief Call – a virtual conversation to learn about your motivations and assess fit.
• Interviews – typically 3, covering technical and cultural fit with your prospective manager and peers.
• Case Study – a role‑play, technical assessment, or problem‑solving scenario tailored to the position.

Responsibilities

• 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.

Qualifications

• At least 6 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 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; 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 of 110+ nationalities.
• A culture that places trust at its core; 70% of leaders start at first‑level responsibilities.
• A robust training system through our internal Academy with 250+ modules.
• A vibrant workplace with internal events such as afterworks and team‑building.
• Strong commitment to CSR, notably via the WeCare Together program.
• Remote policy: possibility to work fully remotely.

Diversity and Inclusion

Amaris Consulting is proud to be an equal‑opportunity workplace. We welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other protected characteristics.

Seniority Level

• Mid‑Senior level

Employment Type

• Full‑time

Job Function

• Management and Manufacturing
• IT Services and IT Consulting

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