Manager, Global Safety Submissions

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Implement strategies and procedures for monitoring and submitting individual case safety reports and aggregate safety reports.

• Assist in generating and reviewing metrics related to submission compliance for ICSR and aggregate report submissions.

• Analyze submission metrics and trends, providing data-driven strategic recommendations to the Global Safety Submissions lead.

• Collaborate with Global Patient Safety, Clinical, and Regulatory teams to ensure adherence to global safety reporting obligations.

• Aid in the development and review of safety exchange agreements/plans with third-party vendors and business associates.

• Work alongside the BeiGene Safety Systems team to ensure the global safety database facilitates submission processes.

• Provide support and oversight for CROs involved in safety reporting to local regulatory authorities, ethics committees, and investigators.

• Assist in the creation and training of department-specific SOPs and work instructions.

• Support pharmacovigilance regulatory inspections and partner audits.

⛳️ Requirements

• Proficiency in English is mandatory.

• Experience in the Pharmaceutical/Biotech industry is preferred.

• Bachelor's Degree with 5 years of relevant experience OR a Master's Degree or higher (such as RN, RPh, PharmD) with 4 years of relevant experience.

• A minimum of 2 years of experience in drug safety/pharmacovigilance is preferred.

• Advanced degree is preferred.

• Strong knowledge of global regulatory requirements, including ICH, GVP, FDA 21CFR312.32, 314.80, GCP, NMPA Announcement No. 66 (2018), and PAL of PRC (Dec 2019).

• Familiarity with safety reporting regulations for clinical development and post-marketing products.

• Exceptional attention to detail and the ability to manage multiple tasks in a fast-paced environment.

• Strong interpersonal and communication abilities.

• Capability to work independently, as well as collaboratively within cross-functional teams and with external partners, vendors, and international colleagues.

• Excellent verbal and written communication skills.

• Clear and confident presentation abilities.

• Proficiency in networking and collaborating within global organizations.

• Results-driven mindset.

• Proficient in safety databases and other necessary platforms and tools.

• Competent in Microsoft Office Suite, including Word, Excel, PowerPoint, and Visio.

🏝️ Benefits

• Full-time employment.

• Remote work arrangement in Brazil.