Supporting Global MSO for below activities: - Provide safety leadership for Clinical
Development including Clinical Study, 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
- 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.
- 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
- 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.
- Chair and/or co-chair on 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 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.
- 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.)
- Support 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.
Qualifications 资格要求:
- MD is preferred; clinical research
and/or fellowship training in oncology, immunology, genetics,
pediatrics, pharmacology or other relevant specialty is a plus.
- Minimum 2-4 years Drug
Safety/Pharmacovigilance experience plus 1-2 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 NMPA, 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
- 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.
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