Associate Director Risk Management (1-year maternity leave replacement)
Munich, Germany; London, United Kingdom; Mainz, Germany | full time | Job ID:9398 Review and medical assessment of legal liability cases received by BioNTech, as prioritized for review and summarization by the legal department
Ensure that the legal department is supported with up-to-date information on the prescribing information of the Comirnaty product in Germany and the rest of the world
Maintaining oversight of the safety profile of the Comirnaty product by participation in JSRTs with collaboration partners, review of aggregate reports (PSURs, RMPs, Signal management documents).
Conduct literature searches and other appropriate inquiries of certain databases regarding health-outcomes and medical treatment-related data in conjunction with legal liability cases.
Ensure documentation and filing of all sources of safety data in the correct document management and filing systems and to ensure that all content is kept up-to-date
Oversee the work of certain assigned scientific and administrative MSPv staff to support the legal department with the handling of legal liability cases.
In addition, as directed by the Director Risk Management, the incumbent may be assigned, direct or under supervision, to: - assist with the medical aspects of postmarketing safety reviews conduct the review of post-marketing safety study protocols to assist with the oversight of postmarketing safety commitments to provide safety input to regulatory and clinical documents, for example, aggregate safety reports, risk management plans, and responses to regulatory authorities assist with projects within MSPv, which require medical insights and expertise
assist with the medical aspects of postmarketing safety reviews
conduct the review of post-marketing safety study protocols
to assist with the oversight of postmarketing safety commitments
to provide safety input to regulatory and clinical documents, for example, aggregate safety reports, risk management plans, and responses to regulatory authorities
assist with projects within MSPv, which require medical insights and expertise
For all other matters in his/her competence, as assigned to him/her on occasion by the Director Risk Management
Education: Medical Degree
Professional Experience - must have, either/or, or accumulated: 3 or more years work experience as practicing physician in the German health care system Good working knowledge of the German health insurance and social security provisions
3 or more years work experience as practicing physician in the German health care system
Good working knowledge of the German health insurance and social security provisions
Holds oneself accountable for achieving high ethical standards in work and behaviors
Maintains a critical, dispassionate attitude also with increasing complexity or urgency
Deploys good clinical judgement in adjudicating causality assessments to safety observations
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.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:Only applications sent via our online form shall be considered. 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.
We are looking forward receiving your application.