Manager, Global Safety Submissions

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION Language Requirement: Fluent English is Required Preferred Experience: Pharmaceutical/Biotech Industry Location: Brazil Remote General Description: Works with direct manager and other Global Patient Safety team members to execute the strategy and processes defined for monitoring and submitting individual case safety reports & aggregate safety report submissions to regulatory authorities, investigators, ethics committees, business partners and other applicable recipients for BeiGene’s marketed or investigational products. Essential Function: • Assists in the production and review of submissions compliance metrics for ICSR and aggregate report submissions to regulatory agencies, partners, ethics committees and investigators. • Analyzes submissions metrics and trends to provide data driven strategic recommendations to the Global Safety Submissions lead. • Collaborates with Global Patient Safety, Clinical and Regulatory functions to ensure awareness and compliance of all safety reporting obligations to global regulators and partners. • May assist in the development and review of safety exchange agreements/plans with third-party vendors and business partners. • Collaborates with the BeiGene Safety Systems team to ensure the global safety database can support submission processes. • Provides support and assists with oversight activities of Contract Research Organizations (CROs) involved in safety reporting to local regulatory authorities, ethics committees and investigators. • May assist in the development and training of department-specific SOPs and Work instructions to ensure procedures are in place to support a global submissions process. • May support PV regulatory inspections (FDA, MHRA, CFDA, etc.) and/or partner audits. Minimum Requirements – Education and Experience: Bachelor’s Degree with 5 years relevant experience OR Master’s Degree or above (such as RN, RPh, PharmD) with 4 years relevant experience Other Experience: At least 2 years of experience in drug safety/pharmacovigilance experience preferred. Advanced degree preferred Strong understanding of Global regulatory requirements (i.e. ICH, GVP, FDA 21CFR312.32, 314.80, GCP, NMPA Announcement (No. 66, 2018), PAL of PRC (Dec 2019)) for capture and submissions of pharmacovigilance individual case safety reports and aggregate safety reports to FDA, CDE/NMPA, EMA, MHRA, and other global regulatory authorities/national competent authorities Knowledge of safety reporting regulations for clinical development & post-marketed products Strong attention to detail and the ability to multi-task in a fast-paced environment Strong interpersonal and communication skills and the ability to effectively work individually, within a cross-functional team, as well as with external partners, vendors and overseas colleagues. Excellent communication skills (verbal and writing); clear and confident presentation skills; ability to network and partner within global organizations; results oriented and strong attention to detail Supervisory Responsibilities: N/A Travel: N/A Computer Skills: Safety database and other platforms and tools as required, MS Office suite including Word, Excel, PowerPoint, and Visio #LI-Remote Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.