Drug Safety Lead - Remote

Detalles de la oferta

The Position Supports the Clinical Safety and Risk Management (CSRM) team in the safety surveillance of assigned products. Proficient in retrieval, data preparation, and preliminary analysis for, and quality assurance of, prepared responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences reported with Company products. This includes the authoring of Periodic Safety Update Reports (PSURs) and other regulatory documents. With guidance from CSRM team assists with the safety surveillance review of adverse experience (AE) reports and with the development and evaluation of risk management plans (RMPs). Responsibilities Leads signal detection, safety evaluation and risk management planning and activities for low-medium complex medicinal products and/or medical devices during clinical development and/or for established brands from a scientific perspective. Lead Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix. Lead the safety contributions to global regulatory submissions. Ensure that appropriate safety objectives and risk minimization strategies are included in clinical development programs. Expert evaluation for literature review, clinical data synthesis, analysis, and interpretation. Ensure that the scientific safety assessment of individual development assets is driven by comprehensive and customer-focused strategic patient safety expertise. Accountable for Signal management of assigned products, timely handling of signal evaluations and benefit/risk assessments for assigned products. CCDS/CCSI and key local labels (SPC, USPI, PIL) safety sections. Risk management planning (RMP) and Additional Risk Minimization Measures (ARMM) development and execution. Responsible for Evaluation strategies and RMST presentations as well as adequate documentation. The creation of Aggregate Safety Reports (ASR) and Risk Management Plans (RMP). Safety related activities of clinical studies when applicable. Evaluation strategy, presentations and timely response to internal and external requests. To take over activities of new medicinal product/device integration if applicable. Qualifications/Skills (professional And/or Technical) Excellent Analytical skills, to evaluate, interpret, present and critically discuss safety data. Highly effective communication and influencing skills. Excellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations, GCP). Good computer literacy with experience with safety databases and other IT systems. Ability to prioritize tasks and consistently deliver on deadlines. Fluency in English. Collaborative and team orientated; ability to set up and implement Drug Safety strategies. Experience 3-5 years of PV experience in the pharmaceutical industry. Expert knowledge in pharmacovigilance and methodologies in a global environment. Sound knowledge of the therapeutic area of assigned products. Experience in Medical Device product quality regulations and safety monitoring is a plus. Education / Certificates MD-degree with several years of clinical experience. MD/PhD/MSc Equivalent with experience in International Drug Safety. #J-18808-Ljbffr


Salario Nominal: A convenir

Fuente: Whatjobs_Ppc

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