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
MD, Pharmacist or PhD/advanced science degree.
Native in written and spoken Japanese.
Fluent in written and spoken English.
Necessary Professional Experience
MD: Clinical experience (preferably ≥ 2 years); Pharmacist, PhD/advanced science degree: pharmaceutical industry experience (preferably ≥ 5 years) in an affiliate setting preferably in R&D organization or similar (e.g. Health Authority)
Advanced experience in Pharmacovigilance (preferably both in the clinical development as well as the post-marketing area)
Experienced in working in cross-functional, global teams, across different regions.
