Sr. Manager Pharmacovigilance and Operations

Ascentage Pharma: (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company engaged in developing novel therapies for cancers and other diseases. Ascentage Pharma is proud of its collaborative, supportive culture, unified by the desire to develop therapeutics that will have a positive impact on patients’ lives. Ascentage Pharma is a dynamic and fast-paced organization that has been responsive to the needs of individual employees throughout its history.

The company is defined by a shared understanding it succeeds in advancing its mission only as each individual experiences’ success in their role.

Leveraging our robust internal research and development capabilities, we have built a portfolio of global intellectual property rights. We have also established global collaboration relationships with leading biotechnology and pharmaceutical companies, such as AstraZeneca, Innovent, Merck, and Pfizer and research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, MD Anderson Cancer Center, National Cancer Institute and the University of Michigan.

We are a leader in global innovation with a portfolio of more than U.S. and international patents and more than U.S. and international pending applications. We have assembled a talented, global team with experience in the research and development of innovative drugs. Our success is shaped by this global team of 700+ employees across United States, Europe, Australia, and China and we are looking forward to adding to this great team.

The Senior Manager, Pharmacovigilance Operations plays a critical role in delivering high-quality, compliant safety operations across Ascentage Pharma's global clinical development programs in a fast-paced, post-IPO environment. This role is responsible for the execution and oversight of core PV operational activities, including clinical program safety support, vendor performance management, ICSR quality oversight, and the development and maintenance of pharmacovigilance systems and documentation.

• Manage PV Operations team deliverables with high quality, compliance and strong attention to detail
• May be responsible to process ICSRs or validate quality of vendor responsible for processing ICSRs, including regulatory submission
• Oversee and facilitate ICSR workflow to ensure case processing to internal and regulatory timelines, including engagement of cross-functional stakeholders for timely completion of medical review and/or collection of complete safety information
• Ensure Global clinical trials and/or post-marketed case reporting process is efficient and compliant with reporting requirements detailed in the Ascentage procedures/ safety management plans (SMP) / PV agreements/ local and international regulations
• Contribute to workload management and forecasting
• May act as functional representative on cross functional study teams or product teams as assigned, providing subject matter expertise and facilitating escalation to Head PV Operations as appropriate.
• Responsible for supporting the safety and pharmacovigilance efforts for the pipeline and portfolio by ensuring integrity of data in global safety database, and providing report listings that are validated (programmatically or manually)
• May be responsible for operational tasks related to maintaining the pharmacovigilance documentation required for the electronic Trial Master File documents, including quality review, organization, maintenance, and storage following study procedures
• Collaborate with domestic and oversea cross-functional teams and establish and maintain a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
• Support adverse event reporting or other shared PV Operations team mailbox management and monitoring, including triage and archiving of all email
• Adverse event intake, processing, submission and archiving in accordance with GxP and Ascentage policies and procedures.
• Support the development and maintenance of PV quality management system.
• Support the preparation and review of key pharmacovigilance documents in accordance with company policies and procedures, e.g., Development Safety Update Report (DSUR), Periodic Safety Update Reports (PSUR), safety sections of Clinical Study Report (CSR), Informed Consent Form (ICF), Study Protocol, etc.
• Manage and communicate with external partners to ensure drug safety compliance, if applicable.
• Support the development and maintenance of the safety database and other safety systems tool(s), if applicable.
• Maintain working knowledge of relevant regulations and company SOPs on pharmacovigilance operations activities, including but not limited to, AE/SAE monitoring and reporting procedure, ensure the submission of safety reports to relevant parties complying with the regulatory requirements
• Track and perform impact…