Pharmacovigilance (PV) Consultant

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 +44 (0)20 3854 7700.