Director Benefit Risk Management (m/w/d)
Cambridge, US; London, United Kingdom; Mainz, Germany; Munich, Germany | full time | Job ID:9209
The Director* Benefit Risk Management leads and maintains the global processes and governance for global and local safety risk management planning and for structured benefit-risk assessment (sBRA) in medical safety and pharmacovigilance to ensure patient safety and compliance with global regulatory and quality standards in alignment with company policies.
Act as benefit-risk lead and process expert as member of the Center of Excellence for benefit risk and risk management. Guide safety management teams (SMTs) by moderating benefit-risk workshops, providing training on sBRA principles and best-practices, selection of data sources to evaluate safety data throughout product lifecycle across BNT's pipeline, in order to facilitate internal decision making as well as regulatory submissions.
To oversee structured benefit risk assessment and risk management activities for assigned BioNTech products through their development lifecycle management activities across multiple regulatory regions (EU,US, global) to ensure compliance with global regulatory and quality standards.
Provide guidance to SMTs on the selection of qualitative and quantitative sBRA methodologies and support the evolution from simple to complex evaluations from early to late product development, ensuring readiness for BLA/MAA submissions.
Lead implementation of safety risk management process across the different portfolios
Act as expert for global RMP process as well as local RM requirements in collaboration with local affiliates. Offers process and content guidance in cross-functional SMT discussion for risk management plan planning and writing as well as for the selection of additional risk minimization measures and additional PV activities as well as their implementation and tracking.
Prepare and conduct trainings, templates related to risk management and sBRAs. Act as expert for filing of sBRAs/RMPs in applicable data management systems
In collaboration with the Safety Strategy Lead and SMT, support PV-deliverables for MAA/BLA submission and selection and implementation postmarketing safety requirements, such as labeling discussions, competitor analysis
To participate in medical governance committees to present sBRA and RMP strategy, as appropriate
To represent MSPv in the Global Product Labelling Committee to ensure harmonization between risk management and labeling processes.
Mentor junior PV scientists, safety managers, safety physicians.
Stay abreast of evolving global pharmacovigilance regulations and methodologies and integrate best practices into company processes
Medical degree, Pharmacist or Advanced Degree in Life Sciences (e.g. Epidemiology), in addition, PhD and/or post-graduate training in relevant discipline, e.g., Pharmacovigilance preferred
Several years of leadership experience in pharmacovigilance of products from early to late development as well as marketed products and/or medical safety experience in clinical trials in the biotech or pharmaceutical industry
Experience in oncology and/or infectious diseases and vaccine development
Expert knowledge of global pharmacovigilance regulations and processes, strong understanding of ICH, GVP/GCP modules as well as EU- and US- legislations
Experience as benefit-risk lead, RMP lead, safety physician or safety scientist, safety epidemiologist or similar roles in clinical development, preferably surveillance of safety of vaccine and oncology product development
Expertise in structured benefit risk assessments including knowledge about key qualitative and quantitative methodologies and applicable visualizations (e.g. value trees)
Expertise in moderating cross-functional safety management teams
Expertise in authoring, leading RMPs and experience with selection, implementation of risk minimization measures, risk management, and set-up and management of post-authorization safety studies
Expertise in the methods of signal detection and evaluation in clinical development and post-marketing environment
Competence in the interpretation of results from clinical studies as well as real world data sources
Experience interacting with global health authorities (EMA, FDA, PMDA)
Proactive, solution-oriented with a collaborative mindset
Ability to work effectively in global, cross-functional teams often involving multiple companies
Good communication skills; is able to express complex matters in concise, clear language
Excellent English skills
It's our priority to support you:
Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare