北京招聘

Supporting Global MSO for below activities:

1. Provide safety leadership for Clinical Development including Clinical Study,
   Investigator Sponsored, Compassionate Use, and other Programs; liaise
   with Clinical Development, Clinical Operations, Medical Affairs.
2. Biometrics, Regulatory Affairs, CROs, Data Monitoring Committees (DMCs)
   and other entities to contribute to overall study execution while
   ensuring safety strategy and operational excellence.
3. Provide safety leadership to Commercial organization to support global launch
   activities for assigned products if applicable.
4. Responsible for the preparation and review of safety-related section(s) for clinical,
   regulatory, and scientific documents including protocols, informed
   consent 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.
5. Responsible for 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.
6. Responsible for 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.
7. Chair and/or co-chair on Safety Management Team (SMT), Product Benefit Risk Committee (PBRC), and
   other executive forums for assigned products.
8. 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.
9. 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.
10. Provide medical review of individual case safety reports (clinical and spontaneous) 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.
11. Develop or support to the 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.)
12. Support inspection readiness activities, internal audits and external inspections.
13. 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).
14. Provide safety expertise to due diligence activities as needed.
15. Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.
16. Mentor junior medical office staff; develop and provide training within specific areas of
    knowledge.

Qualifications：

1. MD required; clinical research and/or fellowship training in oncology, immunology, genetics, pediatrics,
   pharmacology or other relevant specialty is a plus.
2. Minimum 2-4 years Drug Safety/Pharmacovigilance experience plus 2 years clinical development
   experience; other relevant experience may be considered.
3. 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 NMPA, FDA and other regulatory authorities is
   preferred.
4. 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
6. Must have excellent written and oral communication skills, resourcefulness and personal organization skills
   together with demonstrated cross-functional teamwork.
7. Some national/international travel may be required.