Manager, Global Safety Submissions

• Execute strategies and processes for monitoring and submitting individual case safety reports and aggregate safety reports
• Assist in producing and reviewing submission compliance metrics for ICSR and aggregate report submissions
• Analyze submission metrics and trends and provide data-driven strategic recommendations to the Global Safety Submissions lead
• Collaborate with Global Patient Safety, Clinical, and Regulatory functions to ensure compliance with global safety reporting obligations
• Assist in developing and reviewing safety exchange agreements/plans with third-party vendors and business partners
• Collaborate with the BeiGene Safety Systems team to ensure the global safety database supports submission processes
• Support and assist with oversight of CROs involved in safety reporting to local regulatory authorities, ethics committees, and investigators
• Assist in developing and training department-specific SOPs and work instructions
• Support pharmacovigilance regulatory inspections and partner audits

• Fluent English is required
• Pharmaceutical/Biotech industry experience preferred
• Bachelor’s Degree with 5 years relevant experience OR Master’s Degree or above (such as RN, RPh, PharmD) with 4 years relevant experience
• At least 2 years of drug safety/pharmacovigilance experience preferred
• Advanced degree preferred
• Strong understanding of global regulatory requirements, including ICH, GVP, FDA 21CFR312.32, 314.80, GCP, NMPA Announcement No. 66 (2018), and PAL of PRC (Dec 2019)
• Knowledge of safety reporting regulations for clinical development and post-marketed products
• Strong attention to detail and ability to multitask in a fast-paced environment
• Strong interpersonal and communication skills
• Ability to work individually, within cross-functional teams, and with external partners, vendors, and overseas colleagues
• Excellent verbal and written communication skills
• Clear and confident presentation skills
• Ability to network and partner within global organizations
• Results-oriented approach
• Proficiency with safety databases and other required platforms and tools
• Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Visio

• Full-time employment
• Remote work arrangement in Brazil