Regulatory Affairs & Pharmacovigilance Manager

We are seeking a Regulatory Affairs & Pharmacovigilance Manager to lead our RA/PV team and ensure regulatory compliance and robust patient-safety systems across our clinical trials and client projects.

Key Responsibilities

• Lead, develop, and support the RA/PV team, managing workloads and serving as the primary regulatory and safety contact for clients.
• Oversee clinical trial submissions and communications with Regulatory Authorities and Ethics Committees, and provide regulatory sign-off on key study documents.
• Manage safety reporting, including SUSARs, ICSRs via EudraVigilance, PSURs, and ASRs, as well as signal detection, safety databases, and Safety Management Plans.
• Act as the EU or Local QPPV, or Deputy, where required, including oversight of the PSMF and RMP.
• Ensure GVP compliance and inspection readiness while supporting business development and continuous process improvement.

Requirements

• Degree in Pharmacy, Medicine, Life Sciences, or a related field.
• Strong knowledge of ICH-GCP, the EU CTR, FDA regulations, and GVP.
• Hands-on experience with regulatory submissions and pharmacovigilance, including EudraVigilance and MedDRA coding.
• Experience with PSMFs and RMPs is an advantage.
• Proven experience leading teams in a regulated environment.
• Analytical, client-focused approach with excellent communication skills.
• Fluency in English.

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