Manager, Global Safety Submissions

BeiGene, Ltd.; Brasil; Remote; BRL 150,000 - 190,000; Full time

Job summary

BeOne seeks a seasoned Global Safety Submissions professional to drive and review pharmacovigilance submissions for regulatory authorities and partners. You will work with global teams to ensure compliance and timely reporting across multiple products in a dynamic, fast-paced setting.

The role requires a strong background in drug safety, regulatory knowledge, and excellent communication. Remote Brazil work arrangement with opportunities to collaborate worldwide.

Qualifications

• Bachelor’s degree with 5+ years relevant experience; or MS with 4+ years.
• At least 2 years of drug safety/pharmacovigilance experience.
• Strong understanding of global regulatory requirements for safety submissions.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Assist in production and review of safety submissions and metrics.
• Analyze submission data and provide strategic recommendations.
• Collaborate with Global Safety, Clinical and Regulatory teams on safety obligations.
• Support safety database operations and oversight of CROs.
• Help develop and train SOPs and support PV inspections.

Skills

Excellent communication skills

Fluent English

Strong attention to detail

Team collaboration

Education

Bachelor’s Degree in relevant field

Master’s Degree or above (RN, RPh, PharmD)

Tools

MS Office

Excel

Word

PowerPoint

Visio

Job description

Overview

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. 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

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

EEO / Diversity

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.

About BeOne

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting

Values

At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit