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Onsite Director, Medical Safety – Pharmacovigilance, Safety Strategy Lead
Posted last week
About the role
- Safety Strategy Lead at BioNTech managing a team for safety governance and regulatory compliance in China. Responsible for formulating safety strategies and ensuring product safety oversight.
Responsibilities
- The Safety Strategy Lead China represents a pivotal function in the BioNTech Safety Governance; therefore, the SSL assumes accountability for: an optimal performance of the cross-functional safety management team(s) under his/her leadership in the local as well as global setting with active contribution when needed
- formulating and driving the development safety strategy for the programs under his/her leadership
- the detection, evaluation and decision-making on safety observations as well as the assessment of the Benefit/Risk balance; with escalation of emerging safety risks where appropriate to the Head of Medical Safety and/or Head of MSPv and the Executive Safety Council
- leads a team of safety physicians
- oversees (or leads) the safety management team(s), responsible for the safety monitoring, benefit-risk assessments and risk management of the assigned products in development and/or marketed
- ensures that single case reporting, signal management and risk management activities which occur under his/ her direction and competence, are performed at all times in compliance with applicable law, global and local regulations and in high quality
- is responsible that the safety management team(s) maintain(s) a core safety information for each of the products in development that is up-to-date
- is accountable for the quality and timeliness of the medical safety review of and contributions to clinical and regulatory documents concerning the portfolio products
- is medical safety subject matter expert for the assigned products (in development or post-authorization) and is the arbiter for safety related issues as they may arise
- is responsible for formulating and driving the optimal development safety strategy for the products or product combinations in clinical development at the portfolio level
- may decide in consultation with the Head of Medical Safety that an emergent safety issue/product alert deserves escalation to the Executive Safety Council for arbitration and/or action
- contributes and/or oversees delegated contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings globally with focus also on local China requirements, clinical study report safety conclusion section, responses to key regulatory authority inquiries on products in development and the authoring of safety components of other regulatory documents
- represents MSPv in joint oversight committees concerning collaborative programs with development partners
- upon request, may support business support in due diligence activities regarding review of assets of interest or asset investments/divestments
- assumes accountability for the planning and implementation of inspection readiness
Requirements
- Medical Degree
- In addition, a PhD and/or clinical specialization such as internal medicine, clinical oncology, infectiology is preferred
- At least 8 years of experience in the innovative pharmaceutical industry, of which at least 3 years of medical safety leadership experience in the development of advanced therapeutic medicinal products and/or cellular therapy and/or immuno-oncology products with focus on local China requirements with profound in experience in the global environment; or equivalent in vaccine development
- Experience in the safety requirements for products in the postmarketing setting
- Demonstrable experience in creating and implementing a safety strategy for development program of innovative oncology products; or equivalent in infectious disease/vaccination programs in both the translational safety and early clinical development phase and late stage development and filing activities with focus on China requirements
- Significant experience in contributing to preparation of interactions with Regulatory Agencies including document drafting and participation in meetings with CDE and other Health Authorities on safety topics.
- Experience in overseeing, training and line management of medical safety staff
- Have achieved demonstrable results with a multidisciplinary team in a matrix organization
- Above-average communication skills: able to express complex analyses in concise, clear language; finds persuasive arguments; and an excellent command of the English language
- Competent in analyzing safety data from clinical programs in all phases of clinical development and postmarketing setting; to comprehend and analyze complex data
- Deploys good clinical judgement in detecting and assessment of potential safety signals and/or risks
- Identifies strategic and tactical opportunities to accelerate achievement of development targets
- Can work on solutions for multiple perspectives; pursues questions efficiently and thereby brings issues to their most accurate conclusion
- Holds him/herself accountable for achieving high ethical standards in work and behaviours.
Benefits
- BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
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