Pharmacovigilance and Regulatory Affairs Expert
Send a job offer directly to this candidate
An accomplished professional with impressive experience in Pharmacovigilance, Drug Safety, Aggregate Reports, Signal detection, Risk management, Case Processing, Data Entry, Medical and Narrative Writing, Quality Assurance (QA), MedDRA coding and Literature Search and Review.
I have a master’s degree in pharmacy and over 9 years of Pharmacovigilance experience, with a focus on aggregate reports, ICSR processing, and literature research. I have successfully managed signal detection and risk management activities for various therapeutic areas.
Currently, I work as a Management Information Specialist for Client Services at Health Assured in Manchester, where I handle client management tasks. Previously, I was the Periodic Reporting Expert Oversight at IQVIA, leading a team of 6 medical writers and ensuring the quality and compliance of aggregate reports, ICSRs processing and literature review. Before that, I was the Business Process Lead at Tata Consultancy Services, overseeing the preparation and review of aggregate reports and supporting Health Authority inspections and audits.
I have also developed and maintained SOPs, QC checklists, job aids, and templates for process improvement and training purposes. I am proficient in Safety database management (Argus, ARISg/LifeSphere Safety, Veeva Vault, Salesforce, PowerBI/Tabeleu), Microsoft Office (Excel, Word, Power Point, Teams, Outlook) and MedDRA coding.
I have a UK work permit until Jan 2025 and will need sponsorship afterwards. I am willing to relocate anywhere in the UK for the job.
