Job Summary

A biopharmaceutical medical research firm needs applicants for an opening for a Remote Research Senior Manager.

Candidates will be responsible for the following:

• Authoring large complex documents summarizing aggregate data (PSUR/PBRERs, DSURs) based on extensive experience
• Managing complex timelines to achieve on time completion with cross-functional collaboration and delivery of key documents
• Being lead author for Safety Reviews based on extensive experience: design search strategy and evaluation methods

Qualifications Include:

• MS/MA in life sciences, biology, medical or pharmacy-related and 6+ years of experience in pharmacovigilance
• Extensive experience in preparing global periodic safety reports
• 7+ years direct pharmacovigilance experience performing the above responsibilities
• Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines
• Experience working with safety databases