Your main responsibilities are:
* 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
What you have to offer.
* 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
Your Benefits:
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
Apply now - We look forward to your application!
Apply to our Cambridge, US; London, United Kingdom; Mainz, Germany; Munich, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 9209 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.