Beschreibung
The role of the GPS Safety Strategy Lead (E4) is to ensure the delivery of integrated medical safety strategies for assigned development compound(s) and/or marketed product(s) including proactive safety surveillance and effective signal and benefit-risk management.For assigned product(s), either directly or through effective delegation to other members of the GPS Product Team:
• set the medical safety strategic direction, in the context of delivering the benefit-risk profile, and provide clear, strong and visible safety scientific leadership, in partnership with R&D cross-functions
• ensure oversight of the emerging safety profile of the product, including medical review of individual case safety reports as required, signal detection and evaluation, periodic safety reporting, risk-benefit evaluation, and risk management throughout the lifecycle of the product
• ensure that safety signals are identified promptly and communicated/escalated within the company appropriately
• ensure high-quality medical safety contributions to Pharmacovigilance Advisory Board (PVAB)
• develop and leverage medical safety strategic contributions to other R&D governance bodies and review committees (e.g. DSC, MSEB, GMDB)
• represent GPS on cross-functional teams for the product, including e.g. the Global Program Team (GPT) and any Alert Action Teams, ensuring that all negotiated and agreed deliverables and deadlines for these teams are met
• represent GPS at submission teams and provide safety strategic input into submission documents such as Integrated Summary of Safety, Clinical Summary of Safety (Module 2.7.4), Clinical Overview (Module 2.5) as well as safety update reports
• chair the BRAT and SMCs as required
• represent GPS on safety aspects for the product externally, e.g. engagement with external SMC/IDMC members
• preparation for and attendance at regulatory authority meetings, interactions with external advisers or opinion leaders, effective collaboration with colleagues from partnership companies for co-development or co-marketing
• act as a subject-matter expert on medical safety in interactions/discussion/negotiations with regulatory authorities
• ensure effective communication of product-related aspects in audits and regulatory authority inspections
• provide medical safety expertise for due diligence activities as required
• provide efficient oversight for medical safety activities in support of outsourcing and offshoring models
• maintain a profound level of knowledge about the product and the therapeutic area
• provide product- or TA-specific training to GPS colleagues, and safety training to non-safety colleagues, as required
• coach, support and help develop other GPS staff in relevant GPS Product Teams
Skills / Profil
• Several years of medical experience as a physician, preferably clinical experience in the relevant therapeutic area
• Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience; excellent knowledge of the pharmacovigilance regulations/guidelines and its application for activities related to assigned product/s
• Excellent knowledge of product development process and experience of cross-functional teamwork
• Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
• First-hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good medical understanding of the relevant therapeutic area(s)
• Expert knowledge of aggregate data analytics and understanding of related sciences such as predictive modeling, epidemiology, health outcomes, and biostatistics
• Professional experience in a global matrix environment across regions
Application:
https://www.gulp.de/gulp2/g/projekte/agentur/a0w3X00000S308OQAR