Job Description
Your new company
My client is a global biopharmaceutical company with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people's quality of life, specialising in Oncology, neurology, rare diseases, ophthalmology and immunology. There is an opportunity for an Associate Director / Director Safety Scientist to join their team.
Hybrid 40% in office
Your new role
As a highly motivated individual, you will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting, this may include signal evaluation, safety-related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.
- Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas
- Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
- Responsible for signal detection and management activities and contributing to the strategy and review of safety assessments and drug safety reports for signals or iss...