Global Safety Submissions Manager — Remote

BeiGene; United States; Remote; USD 24,000 - 36,000; Full time

Job summary

BeOne is seeking an experienced professional to support global pharmacovigilance submissions and compliance for regulatory safety reporting. You will work with the Global Patient Safety team to monitor, prepare, and submit individual case safety reports and aggregate safety reports to regulators, investigators, and partners.

The ideal candidate holds a Bachelor’s with 5+ years of relevant PV experience or a Master’s degree with 4+ years, and has strong knowledge of ICH, GVP, and FDA safety

Qualifications

• Bachelor’s Degree with 5+ years relevant experience.
• 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.
• Strong understanding of global regulatory requirements (ICH, GVP, FDA rules) for safety reporting.

Responsibilities

• Assist in production and review of submissions compliance metrics for ICSR and aggregate reports.
• Analyze submissions metrics and trends to support strategic recommendations.
• Collaborate with Global Patient Safety, Clinical and Regulatory functions to ensure awareness and compliance of safety reporting obligations.
• Assist in development and training of department SOPs and work instructions.

Skills

Attention to detail

Communication

Cross‑functional collaboration

Data analysis

Education

Bachelor's Degree

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

Tools

Safety database

MS Office (Word, Excel, PowerPoint)

Job description

BeOne is seeking an experienced professional to support global pharmacovigilance submissions and compliance for regulatory safety reporting. You will work with the Global Patient Safety team to monitor, prepare, and submit individual case safety reports and aggregate safety reports to regulators, investigators, and partners.

The ideal candidate holds a Bachelor’s with 5+ years of relevant PV experience or a Master’s degree with 4+ years, and has strong knowledge of ICH, GVP, and FDA safety