Senior Manager, Pharmacovigilance Operations

Company Description K2 Therapeutics is a biotechnology company purpose-built to acquire, develop, and advance high-quality therapeutic assets for global markets. Headquartered in Singapore, K2 serves as a strategic platform for the in-licensing and global development of innovative therapeutics, including programs originating from China, with the goal of advancing them through key clinical development and value-creation milestones to benefit patients worldwide.

The company is backed by MPM BioImpact, a leading global biotechnology venture capital firm with a multi-decade track record of company creation, development, and value generation. Leveraging MPM BioImpact's deep expertise in global clinical development and extensive industry network, K2 is positioned to efficiently advance promising therapies across international markets.

Operating under a fully outsourced clinical development model, K2 partners with leading contract research organizations (CROs), pharmacovigilance vendors, and other specialized service providers to deliver high-quality and efficient clinical programs.

Role Description The Senior Manager, Pharmacovigilance Operations is a full-time, on-site role based in Singapore. The role is responsible for ensuring compliant, high-quality, and inspection-ready pharmacovigilance processes across global clinical trials, including safety case management, expedited reporting, PV vendor oversight, aggregate reporting support, safety governance, and inspection readiness. The successful candidate will work closely with Clinical Development, Regulatory Affairs, Clinical Operations, and external CRO partners to ensure efficient execution of K2's global safety strategy.

This is a highly visible role with significant responsibility for establishing scalable PV infrastructure to support K2's growing development portfolio.

• Lead day-to-day pharmacovigilance operations across K2's global clinical development programs, ensuring compliant and efficient execution of all safety activities.
• Serve as the primary operational lead for outsourced PV service providers and CROs, overseeing performance, quality, deliverables, and compliance with contractual obligations.
• Oversee SAE and ICSR management processes, including case intake, processing, quality review, reconciliation, and expedited reporting to ensure compliance with applicable global regulatory requirements.
• Ensure pharmacovigilance activities are conducted in accordance with global regulations and guidelines, including ICH GCP, ICH E2A-E2F, GVP, and applicable local requirements.
• Monitor key PV metrics, quality indicators, compliance trends, and vendor performance; identify risks and drive timely corrective and preventive actions (CAPAs).
• Coordinate preparation and review of aggregate safety reports, including DSURs, and oversee safety data reconciliation activities across clinical, safety, and vendor databases.
• Support Safety Review Committee (SRC) meetings and facilitate cross-functional review and communication of emerging safety issues, signals, and risk mitigation actions.
• Maintain oversight of safety databases, PV systems, and pharmacovigilance documentation to ensure inspection readiness and data integrity.
• Develop, implement, and continuously improve PV processes, SOPs, work instructions, and governance frameworks to support K2's expanding development portfolio.
• Lead pharmacovigilance inspection-readiness activities and support sponsor audits, vendor audits, and regulatory authority inspections, including management of observations and CAPAs.
• Collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, and external partners to ensure effective execution of K2's global safety strategy.
• Contribute to the establishment and scaling of K2's pharmacovigilance infrastructure, vendor oversight model, and safety governance processes as the company advances multiple global development programs.

Qualifications

• Bachelor's degree or higher in life sciences or related field.
• 8+ years of PV Operations experience, including 3+ years in managing outsourced pharmacovigilance activities.
• Solid experience supporting oncology and global clinical trial.
• Strong knowledge of ICH GCP, ICH E2A-E2F, and GVP requirements.
• Hands-on experience with SAE/ICSR management, expedited reporting, safety data reconciliation, and aggregate safety reporting (e.g., DSURs).
• Experience supporting pharmacovigilance inspections, audits, and CAPA management.
• Familiarity with safety databases (e.g., Argus, ARISg, or equivalent) and PV quality systems.
• Fluent in English; bilingual communication in Chinese and English is a plus.