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The purpose of this role is to support the GPS safety strategy lead Japan in order to provide integrated medical safety strategies for the assigned investigational and marketed products. This includes input into safety aspects of clinical development, risk management and benef
it-risk management for assigned products.
Key responsibilities of the Pharmacovigilance Scientist within Safety Science include (but not limited to):
- Support preparing dossiers submitted to Japanese Health Authorities:
- Support Safety Strategy Lead Japan to prepare Safety parts in submission dossiers (CTD 2.7.4, etc ) collaborating with Safety Strategy Lead in Japan, GPS at HQ and other functions in R&D-Japan.
- Prepare and coordinate local & global review for the Japanese periodic safety reports; safety parts in J-PBRER, unlisted/non-serious ADR reports, medical device unknown non-serious defect periodic report and J-DSUR
- Prepare re-examination application dossier
- Support Safety Strategy Lead Japan to draft responses to inquiries from PMDA, and finalize collaborating with Global
- Draft and review coordination of local study reports and reports of safety measure, which could be launched and/or development product.
- Signal detection and management:
- Conduct basic signal detection activities like case triage, medical assessment for Japan cases.
- Reviewing reports and data in dedicated tools (e.g. Spotfire, EVDAS, Empirica Signals, as applicable) for signal detection purposes for Japan data considering the Japanese regulatory requirements for data of Japan
- Reviewing and assessing clinical and safety database output of Japan data; medically/scientifically analyzing and interpreting aggregate safety data from clinical trials and post-marketing sources of Japan to evaluate potential signals/issues
- Reviewing the scientific Japanese literature (non-ICSR literature) for safety surveillance and signal detection purposes
- Supporting the analysis of safety signals originated from Japan (including contributions to the signal evaluation report, and BRAT, PVAB, MSEB and LDB meeting contributions)
- Emerging Safety Issue Reports: supporting the communication to external stakeholders in Japan
- Benefit/Risk Activities:
- Supporting the definition of the safety profile including the definition of important risks/safety concerns specific to Japan
- Supporting the delivery of Japan specific content related input into the core benefit-risk document and associated documents
- Contribute with Japan specific safety related information that can be relayed at wider program meetings (e.g. GPT, BRAT, PVAB etc )
- (d)RMP (updates) and periodic safety reports
- Supporting in developing Japan specific part in RMP (if applicable) and implementing RMPs, including risk minimization measurers with quality, efficiency and timeliness.
- Support the local adaption of RMPs
- Supporting the delivery content related input into periodic safety reports by the following involvement but not limited to
- Author the simple sections of the aggregate safety report(s), e.g. PBRERs, PSURs DSUR
- Contribute to moderate complexity level sections of above mentioned the report(s), e.g. in relation to BR, Signals, etc
- Analyze data from different sources and input relevant data to the report(s)
- Safety input into regulatory filings and associated submission activities
- Contribute with data and evidence needed for regulatory filings, e.g. risk management plan, briefing book，ISS/SCS IAP, Modules 2.7.4 and 2.5, RMP and product information
- Providing content related safety input into Clinical Overview Addendum
- Clinical trial activities
- Supporting the delivery of content related input into the safety sections of the IMPD, IB and ICF
- Supporting the delivery of safety related input into the development of other clinical trial related documents such as clinical trial protocols, integrated analysis plan, clinical trial reports
- Providing safety related input for data monitoring committees (i.e. charters, meeting minutes)
- Inspection/Audit Management
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- Explore findings appropriately to determine whether they are signs of underlying issues or isolated events
- Participate in audit/inspection interviews for medical safety questions of specific products
- Providing responses to queries from auditors/inspectors
- Be a trusted point of contact for drafting CAPA response for BR-related topics all for CAPA process
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- Developing and maintaining MedDRA CMQs for the analysis of potential signals and aggregate safety data
- Developing product-specific trainings for internal or external stakeholders
- Providing expert input into the standardization and improvement of processes within GPS.
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