13 ott - Parma
Chiesi Farmaceutici
Department: Global Regulatory Affairs & Patient Safety
Business Area: R&D;, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location: Europe, remote, IT
About the role
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 vantaggi–risk decisions.
This is what you will do
- 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)
- Works in a fully integrated into a cross‑functional context and deliver to the highest scientific and compliance standards.
- 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 devel
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