Reporting to the Chief Medical Officer, this position will be filled at the Senior Director or Executive Director level. This position will provide strategic oversight of pharmacovigilance (PV) operational activities in support of monitoring the safety profiles of all Apollomics products via best practices in PV to ensure global compliance with FDA and international regulatory reporting requirements in alignment with global health authority guidance including GCP/ICH, compliance requirements, and Apollomics corporate and business partners policies.
Primary Duties and Responsibilities:
- Accountable for day-to-day operational performance and compliance of global PV processes, SOPS, training, and education. Implements pharmacovigilance standards across all development programs that are followed globally.
- Ensures timely submission of pharmacovigilance reports to health authorities.
- Leads data reconciliation between clinical and safety databases data on a routine basis as well as serious adverse event report exchange with different sponsor company.
- Reviews and authors safety sections to study protocols, investigator’s brochures, statistical analysis plans and other clinical study-related documents, in addition to contributing to pharmacovigilance risk management.
- Reviews adverse event data, literature, and other safety-relevant data in order to conduct proactive signal detection activities and leads data analysis to evaluate safety observations.
- Performs triage, review, and assessment of serious adverse events including analysis of similar events and ensures acquisition of appropriate information and timely global submissions as applicable.
- Directs the planning, preparation, writing and review of aggregate reports, including but not limited to, development safety update reports, periodic safety reports, etc.
- Performs periodic reviews of safety information and presentation of this information at Safety Review Committee meetings and cross functional teams as applicable.
- Leads internal audits and regulatory inspections and undertakes activities to maintain a state of inspection readiness.
- Lead the development of safety data exchange agreements, and safety management plans with internal and external stakeholders for clinical studies and ensure compliance.
- Reviews MedDRA/WHO Drug Coding as developed by Safety CRO.
- Provide guidance to pharmacovigilance department in China as needed.
- Leads the oversight of Safety CRO and related Study CROs by ensuring safety functions and deliverables are of high quality in alignment with Master Service Agreement and applicable Statements of Work.
- MD preferred; non-MD doctorate level candidates will be considered
- Oncology clinical trial experience highly desirable.
- Ten plus years’ experience in safety monitoring and pharmacovigilance required.
- PV clinical research experience in a pharmaceutical organization/biotech or global CRO in clinical trials performed according to GCP requirements and intended for filing to regulatory agencies is required.
- Excellent knowledge of US/EU and Rest of World (ROW) relevant global regulations, including but not limited to ICH and FDA guidelines. China PV experience is a plus.
- Strong scientific analytical skills with exceptional attention to detail and the ability to work on multiple complex projects simultaneously.
- Thorough understanding of pharmacovigilance -related information systems.
- Excellent verbal and written communication skills. Ability to speak Mandarin and read Chinese is a plus.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.