Beschreibung
Provides integrated strategic medical and safety expertise; performs active pharmacovigilance with rapid identification and analysis of safety signals; defines emerging drug safety profiles for assigned products and drives patient risk management.• The role of the Global Patient Safety Medical Director TA(s) Neurology & Immunology / Fertility & Biosimilar &
• Anti-malaria / General Medicine & Endocrinology is to ensure effective and proactive medical safety strategies for assigned development compound(s) and/or marketed product(s) in the field of mentioned above including risk management and benefit-risk assessment. This includes the delivery of the medical evaluation of single safety case reports as required based on medical judgment and clinical experience; safety signal detection and evaluation activities; periodic safety reports, risk management plans, and regulatory documents; ensuring definition, implementation, and evaluation of risk mitigation activities, and safety input to clinical trial activities as appropriate.
• For the assigned product or products in close collaboration with Global Safety Strategy Lead:
• Identify and evaluate the risks and thereby contribute to define the safety strategy
• Provide timely and accurate medical evaluation of individual and aggregated safety data from pre- and post-authorization sources, i.e. medical assessment for ICSRs, SUSARs • Ensure correct MedDRA coding of adverse events from assigned case reports • Prepare PSURs/PBRERs, medical assessment for other aggregated safety reports (e.g. EU ASR, 6-monthly SUSAR report) • Ensure provision of a clearly defined safety strategy, in the context of delivering the benefit-risk profile, and ensure that plans in place are consistent with delivering this strategy • Ensure appropriate 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, and that any significant signals or safety issues are escalated appropriately within the company • Ensure delivery of safety aspects to clinical trial activities as appropriate • Represent GPS at submission teams and provide safety strategic input into submission relevant documents including the Integrated Safety Summary (ISS) SAP, Integrated Summary of Safety, Clinical Summary of Safety (Module 2.7.4), Clinical Overview (Module 2.5) as well as safety update reports • Coach, support and help develop the other GPS staff in the relevant GPS Product Team; chair the BRAT and SMCs as required • Represent GPS on cross-functional teams for the product, including e.g. the Global Product Team and any Alert Action Teams, ensuring that all negotiated and agreed deliverables and deadlines for these teams are met (may be delegated as appropriate) • Represent GPS on safety aspects for the product externally, e.g. engagement with SMCs/IDMCs, preparation for and attendance at regulatory authority meetings, interactions with external advisers or opinion leaders, collaboration with colleagues from partnership companies for co-development or co-marketing, etc. • Provide product- or TA-specific training to GPS colleagues, and safety training to non-safety colleagues, as required • Ensure effective communication of product-related aspects in audits and regulatory authority inspections • Provide medical safety expertise for due diligence activities as required
Skills/Profil:
Must have:
• Excellent medical judgment in safety decision-making
• Strong, mature project leadership and influencing skills
• Strong team player and excellent networking skills
• Proven ability to chair meetings effectively
• Solution and results orientated
• Willing to cope with resistance and problems; demonstrated ability to work under pressure and achieving strict timeline targets
• Excellent verbal and written communication skills (in English language)
• Entrepreneurial thinking and striving to move project(s) forward, within budget and timelines