Senior Global Patient Safety Physician

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

Department: Global Regulatory Affairs & Patient Safety
Business Area: R&D;, Pharmacovigilance & Regulatory Affairs
Contract Type: Permanent
Location: Europe, remote, IT
The Senior Global Patient Safety Physician provides safety-scientific and medical expertise to the conduct of safety science activities and safety-related clinical development contributions for assigned development and marketed product(s).
This role requires medical and scientific leadership to ensure that the safety profiles of the concerned products are proactively monitored and assessed, using all available data sources.
The Senior Global Patient Safety Physician can be appointed as the safety science lead (as per the Safety Lead Role Card) to responsibly 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.




Provides safety‑scientific and medical expertise to develop a Safety Science strategy and conduct safety surveillance and risk management activities for assigned development and marketed product(s)
Contributes to a forward‑looking safety surveillance and risk management strategy for the assigned product(s) aligned with regulatory expectations and corporate priorities.
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 BRT
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.
Develops to the d

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