Lead safety signal detection, evaluation, validation, and ongoing signal management activities.
Author and review safety reports, benefit-risk assessments, and risk management plans.
Perform medical evaluation of clinical and post-marketing safety data and identify emerging safety concerns.
Collaborate with cross-functional teams on safety assessments, risk mitigation activities, and regulatory requirements.
Provide medical safety input throughout the product lifecycle and support relevant regulatory submissions.
O pozici / o projektu
Původní popisek. Tech People is a European provider of technical skills permanent recruitment and temporary contracting services for multiple industries.
... Risk Evaluation and Mitigation Strategies - Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up - Providing safety oversight and contribution for label development, review, and updates - Provide medical safety contributions to the Integrated Safety Summary or Common Technical ...
... Risk Evaluation and Mitigation Strategies - Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up - Providing safety oversight and contribution for label development, review, and updates - Provide medical safety contributions to the Integrated Safety Summary or Common Technical ...
... ensuring product safety and regulatory compliance during design and development projects. The following responsibilities are relevant in this role: - Evaluate and interpret World-Wide regulations and standards, guiding design teams to ensure complaint end-product solutions are archived. - Perform technical product design ...
... experience in a Contract Research Organization or Pharmaceutical company combining 4 years of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc.) and 2 years' project management experience • Strong knowledge of applicable global, regional and local clinical research regulatory ...
... Coordinate risk identification, hazard evaluation, and prevention initiatives Requirements - Bachelor's degree in EHS or equivalent combination of experience and training - Minimum 3 years of professional EHS experience - Czech national health and safety certification (OZO in BOZP) - Demonstrated success improving EHS ...
... scenarios and analytical tasks. You will develop detailed reference solutions and assess AI-generated financial models and recommendations against professional standards. Working independently, you will help identify financial inaccuracies, challenge assumptions, and establish robust evaluation criteria. This is a flexible, ...
... functionality and effectiveness of EHS processes (incl. via Gemba, audits, inspections) - Coordinate tasks in the area of risk prevention (identification of hazards and evaluation of risks) - Provide professional assistance to managers with regard to OHS issues at their respective workplaces - Assist managers, process owners ...
... stakeholders - Development of internal security requirements for fraud risk assessment - Development and governance of security assessment, including test results evaluation and findings O pozici / o projektu Původní popisek. Company Description Randstad as Hungary’s most attractive employer in 2025 (according to Randstad’s representative ...
... measures adopted for safety reasons and the risk management plans are carried out. - Establish and maintain a thorough understanding of each project’s budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates. - Provide regular reports to project manager on project metrics, ...
... a mezinárodní spolupráce? Pro našeho klienta, významnou mezinárodní výrobní společnost působící v chemickém průmyslu, hledáme novou posilu na pozici Product Safety Specialist. Co bude náplní práce? • Koordinace registrací chemických látek dle legislativy REACH a dalších mezinárodních předpisů • Sledování legislativních ...