Medical Review Physician

Amaris Consulting; Milano; Remoto; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A global consulting firm is seeking a Medical Review Physician to join their remote team in Milan, Italy. The ideal candidate will have a medical degree and at least 6 years of experience in pharmacovigilance. Key responsibilities include conducting medical assessments, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. The role offers an inclusive work environment and opportunities for professional development.

Servizi

Robust training system

Vibrant workplace events

Strong commitments to CSR

Competenze

• At least 6 years in pharmacovigilance or clinical/medical assessment roles.
• Experience in ICSR case processing, including established products and rare diseases.
• Fluent English for effective communication.

Mansioni

• Conduct full medical assessment of ICSR cases.
• Perform medical evaluation of adverse event reports.
• Ensure medical accuracy and compliance with GVP requirements.

Conoscenze

Pharmacovigilance experience

Medical evaluation skills

MedDRA coding support

Analytical mindset

Effective communication skills

Formazione

Medical degree

Descrizione del lavoro

Job description

Join Amaris Consulting as a Medical Review Physician (remote). Contribute your expertise to a global team dedicated to advancing patient safety and pharmacovigilance excellence. As part of our dynamic environment, you will collaborate with talented professionals and play a key role in ensuring the highest standards of medical review and compliance across a diverse portfolio of products and therapeutic areas.

Your missions

• Conduct full medical assessment of ICSR cases for established products, rare diseases, and priority therapeutic areas
• Perform medical evaluation of adverse event reports, confirming case seriousness and assessing clinical relevance
• Support accurate MedDRA coding, ensuring consistency and proper clinical classification
• Ensure medical accuracy, consistency, and compliance with GVP requirements throughout the case processing workflow
• Contribute to global pharmacovigilance compliance by supporting safety activities and validating medical narratives
• Ensure alignment with global submission standards and Health Authority expectations (EMA, MHRA, FDA)
• Deliver high‑quality medical judgments within regulatory timelines with minimal supervision
• Collaborate effectively with the PV case processing team to ensure end‑to‑end case quality

Your profile

• Academic background: Medical degree
• Experience: At least 6 years in pharmacovigilance or clinical/medical assessment roles
• Extensive experience in ICSR case processing, including established products, rare diseases, and high‑complexity therapeutic areas
• Proven ability to perform detailed medical evaluation of cases, including assessment of seriousness, clinical relevance, and expectedness
• Solid capability to support MedDRA coding, ensuring accuracy, consistency, and proper clinical classification
• Strong working knowledge of GVP modules relevant to case medical review and safety reporting
• Good understanding of global submission requirements and Health Authority expectations (EMA, MHRA, FDA)
• Demonstrated experience in supporting global PV compliance and safety reporting workflows
• Fluent English for effective communication and documentation
• Strong analytical mindset, clinical judgment, and attention to detail
• Effective communication skills for collaboration with PV specialists and cross‑functional teams
• Ability to work with minimal supervision while ensuring high‑quality, timely medical 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.