I provide end-to-end case processing support based on extensive hands-on experience with safety databases such as Argus, Safety Easy, and Veeva Vault Safety. My services include triage of incoming reports, MedDRA coding, narrative writing, quality control, and timely submission of ICSRs to health authorities via gateway or manual channels. I also support mailbox monitoring and ICSR reconciliation processes to ensure consistency and compliance across safety operations.
I support the preparation of aggregate safety reports, including DSURs, PSURs, and PADERs, as well as the generation of SUSAR line listings and monthly safety listings. I have experience preparing regulatory requirements tables and contributing to the development and review of SOPs. I can also support safety data QC and CAPA tracking to maintain inspection readiness and ensure compliance with evolving regulatory expectations.
I support the preparation of aggregate safety reports, including DSURs, PSURs, and PADERs, as well as the generation of SUSAR line listings and monthly safety listings. I have experience preparing regulatory requirements tables and contributing to the development and review of SOPs. I can also support safety data QC and CAPA tracking to maintain inspection readiness and ensure compliance with evolving regulatory expectations.
I assist with TMF filing related to pharmacovigilance documentation in clinical trials, ensuring that essential safety documents are reviewed, organized, and filed correctly. My support includes documentation quality checks and audit preparation activities, in line with GCP and sponsor requirements.
I’ll help you tailor your CV and LinkedIn to match PV job expectations, and prepare you for interviews using real-life questions you’re likely to get asked. Whether you’re just out of school or switching fields, I’ll help you position your experience in the best light.
I’ll help you tailor your CV and LinkedIn to match PV job expectations, and prepare you for interviews using real-life questions you’re likely to get asked. Whether you’re just out of school or switching fields, I’ll help you position your experience in the best light.
My live training sessions are designed to help you understand how pharmacovigilance works in practice. While I don’t provide access to safety databases, I guide you through each step of the ICSR process using real-world logic and examples — from triage to follow-up and submissions.
These sessions are ideal for beginners or those transitioning into PV. We focus on practical workflows, key concepts, and expectations for entry-level roles. Each session is tailored to your experience and goals, with topics like safety terminology, team roles, and what hiring managers look for in junior PV candidates.
