Medical Writer I / Medical Writer II

About the role

We are seeking Medical Writer I or II, Patient Safety to join our team in a hybrid / on-site / remote capacity. As a Medical Writer I or II, Patient Safety, you will support critical pharmacovigilance and safety activities that advance new treatments for patients and ensure regulatory compliance.

What you'll do

• Prepare, compile, and lead development of scheduled and ad-hoc aggregate safety reports including Periodic Safety Update Reports (PSURs)
• Conduct independent signal detection activities by collecting and analyzing safety data from multiple sources including databases, clinical data, literature
• Prepare comprehensive signal assessment documents such as Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs)
• Conduct systematic literature searches and reviews to summarize safety data, identify emerging safety trends, and support signal evaluation and epidemiology assessments
• Manage signal tracking activities, maintain comprehensive signal logs, identify and resolve data discrepancies in safety data sources

What you need

• 4–7 yrs of experience
• Pharmacovigilance
• Microbiology
• Documentation
• Communication
• Any graduate

Good to have

• Clinical research