Senior Medical Writer, Pharmacovigilance

Your newpany

Are you an experienced Senior Medical Writer looking for your next long-term contract opportunity?I am currently partnering with a leading global pharmaceutical organisation seeking a Senior Medical Writer to join their clinical and regulatory writing team on an initial 12-month contract.12-month contractOutside IR35This role sits within a high-performing global team and will suit a writer who is confident leading the development ofplex regulatory and safety documentation whilst collaborating with cross-functional stakeholders across Clinical Development, Pharmacovigilance, Regulatory Affairs, Biostatistics and Medical Affairs.

Your new role

Lead the preparation, review and delivery of high-quality clinical and regulatory documents.Author and coordinate clinical study protocols and protocol amendments.Develop Pharmacovigilance and aggregate safety reports including:DSURs (Development Safety Update Reports)PBRERs (Periodic Benefit-Risk Evaluation ...