Satish Kumar Mahadevaiah Chandraiah, MD

Domain: Hematology, Oncology, Immunology

• Leading GPS Risk Management Team with safety physicians and safety scientists, setting clear objectives and managing skills required to meet project deliverables
• Manage project teams effectively including resource constraints from attrition/ poor performances by team restructuring, outsourcing some activities, streamlining the processes
• Ensure effective collaborations with cross functional teams and co-development partners as the leader or member of benefit risk governance committees (e.g., SMT, benefit risk governance board)
• Represent medical safety in internal (e.g., protocol review committee)/ external committees (e.g., DMC, study steering committee) and audits/inspections as required
• Reviewing/ contributing to the program level documents (e.g., periodic aggregate reports, clinical study reports, protocols/ ICFs, IB, CCSI updates)
• Leading safety in health authority meetings including ISS safety strategy meeting with USFDA, pre-submission meetings with US FDA, EMA and PMDA consultations on Japanese specific trial
• Supported due diligence and divestment activities
• Supported safety operations team on the migration and consolidation of ARGUS safety database and literature review from multiple vendors to one vendor
• Contribute to further development of GPS through knowledge sharing sessions and authoring/ reviewing process documents

Domain: Hematology/ Oncology

• Owns the safety strategy for assigned product and leads the production of the medical safety deliverables (e.g., DSUR, PSUR, RMP)
• As a core member of global program team (cross-functional team), providing strategic inputs to the clinical development program
• Core team member for new indication submission/ submission post-authorization commitments to various health authorities
• Chair of the cross-functional SMT and joint SMT (with license partner)
• Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from various sources (e.g., pre-clinical, clinical trial data post-marketing, literature)
• Responsible for safety management throughout the Life Cycle of the medicinal product
• Responsible for safety strategy of reference safety information in IB, CDS/ local labels
• Leading the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members
• Preparing safety strategy and safety data for internal safety governance boards and health authority Meetings, as required
• Providing expert medical input to trial and Data Monitoring Committee (DMC)
• Medical review of SUSAR and Investigator notifications (IND-ICSR) and approval of sponsor causality.
• Providing support as needed for audits and regulatory authority inspections
• Leading a team of safety physicians as an operational manager

Domain: Hematology/ Oncology

• Monitoring the clinical safety of assigned products including activities such as literature review, evaluation of single cases or signal detection, and responding to safety-related questions as appropriate
• Performing medical assessment and related activities for ICSRs including collecting additional follow-up information as necessary.
• Providing guidance as appropriate to clinical safety operations for the coding and causality/ expectedness assessment of adverse event reports
• Providing inputs into responses to inquiries from regulatory authorities or healthcare professionals on safety issues
• Responsible for aggregate regulatory reports such as PSURs
• Development of RMP in collaboration with other line functions, providing safety inputs to CDS development and updates
• Providing safety inputs for clinical and regulatory deliverables including protocols/ ICFs, clinical study reports, IB, submission documents
• May deputize global program safety lead if required

Domain: Hematology/ Oncology

• Performing medical assessment and related activities for ICSRs including collecting additional follow-up information as necessary, medical evaluation of quality defects, preparation of investigator notifications
• Providing guidance as appropriate to safety operations for the coding and causality/ expectedness assessment of adverse event reports
• Providing input to the inquiries from regulatory authorities and healthcare professionals on safety issues
• Providing inputs to aggregate safety regulatory reports, RMP and SPP
• Perform signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools
• Member of clinical trial team as a trial safety lead and responsible for providing inputs to the protocol, ongoing safety review of the trial data, review of CSR and contribution to study steering committees/data monitoring committee meetings

Domain: Hematology/ Oncology

• ICSR medical review including appropriately requesting follow up information for proper medical assessment
• Providing guidance as appropriate to safety operations for the coding and causality/ expectedness assessment of adverse event reports
• Contribute to sections of PSURs including analytical inputs for identified, potential risks and new safety signals discussed in PSUR
• Perform literature review for PSUR inclusion
• Provide support for preparation of responses to queries from regulatory authorities and health care professionals
• Assist in preparation of product guidance documents if required for assigned products
• Contribution to the RMP updates, DSUR and annual IB updates as required

Domain: Immunology, anti-infectives

• Medical review of ICSRs (solicited and unsolicited) in the areas of immunology, virology and other anti-infectives
• Provide medical evaluation for the cases including medical assessment

Domain: Bioavailability/ Bioequivalence studies

• Review of study protocols and clinical study documents (informed consent document, CRF, CSR)
• Identifying eligible subjects for the study, based on clinical examination and laboratory investigations
• Appropriate management of adverse events
• Monitoring and reporting AE/SAEs as per regulatory timelines

• Teaching clinical pharmacology to medical and dental students
• Involved in basic and pre-clinical research