Ascentage Pharma · 1 day ago
Sr. Manager Pharmacovigilance and Operations
United States
Full-time
Remote
Senior Level
7+ years expAscentage Pharma is a global, clinical-stage biotechnology company engaged in developing novel therapies for cancers and other diseases. The Senior Manager, Pharmacovigilance Operations plays a critical role in delivering high-quality, compliant safety operations across global clinical development programs, overseeing core PV operational activities and ensuring compliance with safety reporting requirements.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
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 assessment of new, or updates to, relevant pharmacovigilance regulations, process and industry practice. Establish and maintain PV working guidance/procedural documentation according to Ascentage policies and procedures, regulations and global standards. Organize relevant training for internal or external stakeholders to ensure safety compliance Maintains current knowledge and understanding of regulations, ICH guidelines and industry practices in relation to pharmacovigilance and keep abreast of new or changes local regulations, process and industry practice
Manage safety data exchange agreements
Author and/or review operational work instructions, SOPs, guidance manuals
Lead continuous improvement initiatives and projects
May have line management responsibility
Qualification
Required
BS, BA from an accredited 4-year college degree in nursing, pharmacy, or other medical or science-related field
Deep understanding of regulations in major markets (EMA, MHRA, FDA, Health Canada), and strong working knowledge of pharmacovigilance standards & practices to pharmacovigilance, e.g. ІСН guidelines, international pharmacovigilance regulation, industry practice, GxP, GCP, GVP, etc
Expert knowledge of PV Operations technical/scientific area, experience with safety databases (i.e. Argus) and safety coding dictionaries (i.e. MedDRA, WHODRUG)
At least 7 years working experience in pharmaceutical industry in a pharmacovigilance operations role
At least 2 years ICSR quality oversight experience
Experience in vendor management
Experience authoring procedural guidance
Experience with quality review or authoring of pharmacovigilance agreements
Excellent organizational and time management skills
Very strong interpersonal skills and communication skills, with the ability to work in a diverse environment
Demonstrated problem-solving skills
Ability to work independently
Preferred
MBA is a plus
PhD highly preferred
Experience in the Oncology therapeutic area
Experience with line management or leading teams is a plus
Project management experience or certification is a plus
Benefits
Exceptional, Medical, Dental, and Vision plans for employees and families.
Employee paid life, STD & LTD as well as a comprehensive insurance package with spouse life Insurance, Critical Illness, and Accident Insurance
401K with an immediate and generous company match
Liberal paid time off
Flexible schedules for employees and (EAP) employee assistance program.
Company
Ascentage Pharma
Ascentage is a clinical-stage biopharmaceutical company that develops drugs for the treatment of cancer.
201-500 employees
H1B Sponsorship
Ascentage Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (3)
2022 (2)
2021 (1)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$504.74MKey Investors
TakedaYuanMing CapitalSDIC Fund Management
2025-07-14Post Ipo Equity· $192.26M
2024-06-20Post Ipo Equity· $75M
2019-10-28IPO
Leadership Team
Yifan Zhai
Chief Medical Officer
Recent News
BioWorld Financial Watch
2026-01-09
2026-01-06
2025-12-05
Company data provided by crunchbase