Pharmacovigilance (Pv) Consultant

Buscojobs; Italia; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A specialist consulting firm is seeking an experienced Pharmacovigilance Consultant for a fully remote role. The successful candidate will deliver strategic PV solutions to clients in the life sciences sector, providing expert guidance, developing risk management plans, and ensuring regulatory compliance. Candidates should have several years of relevant experience, excellent communication skills, and be fluent in English. This position allows for a flexible work environment, ideal for those adept at both independent and collaborative work.

Competenze

• Several years of hands-on experience in pharmacovigilance roles.
• Deep understanding of ICSR management and PV regulations.
• Experience drafting or reviewing RMPs, DSURs, and PSURs.
• Proven adaptability in remote working environments.
• Fluent in English with additional languages desirable.

Mansioni

• Provide expert pharmacovigilance guidance and support.
• Develop, review, and refine PV documents.
• Collaborate with cross-functional teams for compliant R&D safety workflows.
• Support clients for regulatory inspections and audits.

Conoscenze

Pharmacovigilance expertise

Regulatory compliance knowledge

Excellent communication skills

Client-facing focus

Adaptability to remote work

Fluency in English

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 :

1. Provide expert pharmacovigilance guidance and support across R&D stages, including preclinical safety surveillance, clinical safety reporting, and post-marketing safety activities.
2. Develop, review, and refine PV documents, including risk management plans, safety data analysis reports, and periodic safety update reports (PSURs / DSURs).
3. Collaborate closely with clients’ cross-functional teams in safety, regulatory affairs, clinical operations, and data engineering to ensure integrated, compliant R&D safety workflows.
4. 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].

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