Life Scientist as Director (m / f / d)

BioNTech SE; Mainz; Vor Ort; EUR 100.000 - 150.000; Vollzeit

Zusammenfassung

A leading biotech company is seeking a Director to manage global benefit-risk and safety risk management processes. The role involves supporting safety management teams, ensuring compliance with regulations, and leading the implementation of risk management strategies across various portfolios. The ideal candidate will have extensive experience in pharmacovigilance, excellent leadership skills, and an advanced degree in Life Sciences. Join us to influence patient safety and contribute to the development of vital health solutions.

Leistungen

Flexible hours

Vacation account

Company bike

Employer-funded pension

Childcare

Qualifikationen

• Several years of leadership experience in pharmacovigilance.
• Expert knowledge of global pharmacovigilance regulations.
• Experience with benefit-risk assessments.

Aufgaben

• Lead global processes for safety risk management.
• Guide safety management teams through workshops.
• Oversee risk management activities for assigned products.

Kenntnisse

Leadership

Communication

Collaboration

Pharmacovigilance

Risk Management

Ausbildung

Medical degree or advanced degree in Life Sciences

PhD in Pharmacovigilance preferred

Jobbeschreibung

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.

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

Your Benefits : It's our priority to support you :

• Your flexibility : flexible hours | vacation account
• 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 life phases : Employer-funded pension | Childcare