Manager, Pharmacovigilance (BB-0DE3C)
Found in: Neuvoo CN
General Description: Works under the direction of the Global Safety Submissions lead 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 for BeiGene’s marketed & investigational products. Qualification Required: Essential Functions of the job: • Works with direct manager and other Global Patient Safety team members to execute submissions processes for generating, quality review, submitting, and tracking expedited individual case safety reports (ICSR) and aggregate safety report submissions to regulatory authorities and other applicable recipients for investigational and marketed products. • 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. Supervisory Responsibilities: • Not Applicable Follow Us on MoSeeker!
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