Required Technical Skill Set
- Literature: o Literature review to assess ICSR, current safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports).
o Provide MAH comments for selected literature o Review of Literature Strategy o Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER (e. g 5.2.4, 6.2, 9.2, 15 & 16).
o Providing MAH comments to literature presented under literature sections. o Authoring of RMP updates & implementation plans. o Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses.
o Thesaurus used for indexing medical scientific literature, relevant for literature search strategy tailoring (both ad-hoc and systematic).
Review and interpretation of current expert therapeutic guidelines for the purpose of various safety analyses.
o Review of outputs triaged by the safety scientist for scientific accuracy taking into consideration all of the above criteria
- Aggregate Reports:
o Asses the new information received on important safety concerns for the medicinal product.
o Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy
- Signal Management
- Review of various types of listings for Signal Detection
• Understanding of signal journey and knowledge of signal management systems and process requirements. • Perform Signal validation with a summary.
- DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusion and Review
- Tailoring strategy and methodology for signal assessment
- Overall assessment of the signal based on the presented data and respective recommendations for action
- Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy Project Management
- Manage customer interface, communication and deliverables fo