Patient Safety Science Lead

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dq77e

Who we are looking for

This is what you will do

The Patient Safety Science Lead provides safety-scientific expertise to the conduct of safety science activities and safety-related clinical development contributions for assigned development and marketed product(s).
This role requires scientific leadership to ensure that the safety profiles of the concerned products are proactively monitored and assessed, using all available data sources.
The Patient Safety Science Lead is responsible to manage safety surveillance and risk management activities for assigned product(s) and ensure proactive, science‑driven safety evaluation based on predictive safety strategies, robust surveillance, and informed agevolazioni–risk decisions, soliciting medical expertise where required.

You will be responsible for
- Provides safety-scientific expertise to develop a Safety Science strategy and conducts safety surveillance and risk management activities for assigned development and marketed product(s), aligned with regulatory expectations and corporate priorities.




- Works in a fully integrated cross-functional context and delivers to the highest scientific and compliance standards.
- Ensures continuous access to all relevant safety data to support the integrated oversight of emerging safety profiles across the assigned product(s)
- Contributes to the evaluation of safety issues using all relevant data sources
- Collaborates with stakeholders from Clinical Development, Medical Affairs, Regulatory Affairs, Quality, and other functions in the context of the Benefit Risk Team
- Works with clinical teams to implement safety input into clinical development plans, protocols, study documents, and regulatory submissions.
- Develops Health Hazard Assessments for quality complaints and manufacturing deviations, in line with the GMP quality process.
- Participate to the development of safety surveillance and risk management plans and other outputs for assigned product(s) as per relevant procedures, maint

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dq77e