The Global Medical Safety Officer serves as the medical safety expert accountable for the global medical safety strategy and overall safety profile for the assigned products (investigational and marketed) throughout their lifecycle. This role must effectively interface cross-functionally at all levels in the organization, Contract Research Organizations (CROs) as well as with external Regulatory Authorities. This role leads all major pre- and post-marketing safety deliverables including signal detection, benefit-risk evaluation and risk management activities. This role will work together with other medical safety staff including vendors in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.
- Provide safety leadership for Clinical Development including Clinical, Investigator Sponsored, Compassionate Use, and other Programs; liaise with Clinical Development, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.
Provide safety leadership to Commercial organization to support global launch activities for assigned products if applicable.
Lead the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned products.
Direct the creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling.
Lead signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders.
Chair product Safety Management Team (SMT), Product Benefit Risk Committee (PBRC), and other executive forums for assigned products.
Contribute to the preparation of pre- and post- marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products.
Lead risk-benefit evaluations and contribute to preparation of Risk Management/Control Plans (RMPs/RCPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements.
Provide medical review of individual case safety reports (clinical and post-marketing) and all safety analyses to ensure accurate coding, seriousness, expectedness and company causality assessment, appropriate medical interpretation, consistency in case assessment and accurate reporting to Health Authorities, Ethics Committees, and business partners.
Develop or contribute to development of I-Mab or department processes including policies, Standard Operating Procedures and other relevant safety documentation (eg. Safety Management Plans, data entry guidelines, etc.).
Actively involved in inspection readiness activities, internal audits and external inspections.
Participate in the PV vendor selection activities and contribute to vendor governance activities and key performance indicators to ensure safety operation excellence; contribute to the generation of Pharmacovigilance Agreements (PVAs) or Safety Data Exchange Agreements (SDEAs).
Provide safety expertise to due diligence activities as needed.
Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.
Mentor junior medical office staff; develop and provide training within specific areas of knowledge.
- MD is preferred; clinical research and/or fellowship training in oncology, immunology, genetics, pediatrics, pharmacology or other relevant specialty is a plus.
- Minimum 5 years Drug Safety/Pharmacovigilance experience plus 2 years clinical development experience; other relevant experience may be considered.
- Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to China, Americas, European Union and Asia-Pacific territories including a thorough understanding of case processing and other pharmacovigilance processes. Exposure to working relationship with the CFDA, FDA and other regulatory authorities is preferred.
- Ability to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this position.
- Strong leadership skills.
- Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.
- Some national/international travel may be required.
- 至少5年药物安全/药物警戒经验, 2年临床研究经验; 或其他相关经验。