Associate Director Risk Management (1-year Contract)

Munich, Germany; London, United Kingdom; Mainz, Germany | full time | Job ID:9398

The Associate Director Risk Management assumes accountability for the quality and timeliness of the medical safety review or textual contributions to legal liability case assessments. The role holds accountability for the timely and complete forwarding of all new safety-relevant information from legal cases to the global safety database holder. The incumbent displays self-motivation and organization and demonstrates effective team communication. 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.