Director, Principal Patient Safety Scientist - Biopharma

Job description

Location: Barcelona - Spain (3 days working from the office and 2 days working from home) Introduction to the role: The Director, Principal Patient Safety Scientist role provides expertise to multiple and/or single but complex products in different stages of development as needed. He/she provides oversight of safety documents and deliverables for these projects in collaboration with the Global Safety Physician (GSP) and other PV Scientists. He/she leads PV strategy for safety documents and regulatory reports. Main Responsibilities: Leads the strategy for proactive pharmacovigilance and risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate. Provides subject matter expertise in the therapeutic area and across multiple products. Has the ability to lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization. Performs duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products. As a Safety expert leads presentation o...