Provide medical and safety expertise as the Medical Safety and Pharmacovigilance representative in the medical affairs team.
Lead the preparation and delivery of high quality, consistent and compliant safety information for regulatory submission documents.
Lead/develop strategies for safety-related regulatory activities and support interpretation and authoring of safety sections of documents including Investigators Brochures, clinical trial protocols, safety management plans, study reports, integrated safety summary and summary of clinical safety.
Manages and conducts ongoing safety surveillance on assigned products. Oversees the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary.
Organize and conduct safety management meetings for assigned products and responsible for safety surveillance, signal detection and risk management.
Coordinates the development of guidelines and ensures the uniform and timely processing of adverse event reports. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements.
Lead the development and maintenance of general safety signal management methodologies and product specific signaling strategies for assigned products.
Ensure that the safety profiles of assigned HUTCHMED products are accurately and consistently represented in relevant labeling documents, identify and lead updates as required.
Provide support for medical review of individual case safety reports (ICSRs) for assigned products.
Collaborate with Chinese counterparts and others to update them on medical assessment, signal detection and safety risk management practices
Identify opportunities and manage continuous improvement initiatives as related to medical assessment of pharmacovigilance data.
Assist in the creation, review and implementation of SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management.
Bachelor Degree in Science (Pharmacy degree preferred) with minimum 4 years related experience in clinical safety and pharmacovigilance.
Experience in the oncology therapeutic area is preferred.
Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs and global safety regulations are highly preferred.
Experienced in global regulatory environment and processes, and the ability to integrate safety medical knowledge with regulatory and commercial input.
Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance, benefit risk and potential strategic impact of the data and present the findings clearly in both written and oral communications.
Experienced in PV documents and risk management plans.
Thorough understanding of Hong Kong / Macau pharmacovigilance regulations, GCP and ICH guidelines.
Ability to influence, negotiate and communicate with both internal and external stakeholders.
Excellent English (writing and speaking) and excellent mastery of English medical terminology.