Pharmacovigilance (PV) Consultant

Mantell Associates; Milano; Remoto; EUR 50.000 - 80.000; Tempo pieno

Descrizione del lavoro

A specialist consulting firm is seeking an experienced Pharmacovigilance Consultant to deliver strategic PV solutions for clients. This remote role involves guiding clients through R&D safety processes, developing essential documentation, and ensuring compliance for regulatory inspections. The ideal candidate has extensive PV experience and a strong understanding of regulations, alongside excellent communication skills.

Competenze

• Several years of hands-on experience in pharmacovigilance roles.
• Deep understanding of PV regulations and safety signal detection.
• Experience drafting or reviewing RMPs, DSURs, PSURs.

Mansioni

• Provide expert pharmacovigilance guidance across R&D stages.
• Develop and refine PV documents like risk management plans.
• Support client readiness for regulatory inspections.

Conoscenze

ICSR management

PV regulations (ICH, GVP, FDA, EMA)

Safety signal detection

Risk evaluations

Excellent communication skills

Client-facing focus

Descrizione del lavoro

Mantell Associates is partnered with a specialist consulting, technology, and services firm fully dedicated to supporting R&D within life sciences, who is seeking an experienced and driven Pharmacovigilance (PV) Consultant.

In this fully remote role, you will deliver strategic PV solutions to clients - including sponsors, CROs, and biotech innovators - helping them sustainably elevate patient safety and regulatory compliance.

PV Consultant - Responsibilities : Provide expert pharmacovigilance guidance and support across R&D stages, including preclinical safety surveillance, clinical safety reporting, and post-marketing safety activities Develop, review, and refine PV documents, including risk management plans, safety data analysis reports, and periodic safety update reports (PSURs / DSURs) Collaborate closely with clients’ cross-functional teams in safety, regulatory affairs, clinical operations, and data engineering to ensure integrated, compliant R&D safety workflows Support client readiness for regulatory inspections and audits by reviewing PV processes and implementing improvement measures

PV Consultant - Requirements : Several years of hands-on experience in pharmacovigilance roles, ideally within R&D-focused or consultancy settings in life sciences Deep understanding of ICSR management, PV regulations (ICH, GVP, FDA, EMA), safety signal detection, and risk evaluations Experience drafting or reviewing RMPs, DSURs, PSURs, and safety reporting documentation - especially within clinical development contexts Excellent communication and shaping skills, along with a consultative mindset and client-facing focus Proven adaptability in remote working environments, excelling at both independent and collaborative work Fluent in English (additional European languages desirable, depending on client needs)

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at [phone].