Drug Safety Lead - Remote

Görev Tanimi 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). The Position 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 by active participation and contribution to, amongst others, the Organon Asset teams (when available) Risk Management Safety Teams (RMSTs), Safety Review Committee (SRC), LEAD/LAST and other safety related decision-making governance bodies. Safeguard patient from harm. 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 and shows confidence, credibility and influence at all levels of the organization. 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, for effective benefit-risk decision-making. Responsibilities Accountable for Signal management of assigned products, timely handling of signal evaluations and benefit/risk assessments for assigned products and signal detection escalation level for drug safety scientist. 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) i.e. data completeness, accuracy and timely submission to GRA publishing. When applicable (less complex product in post-marketing or new straightforward developmental asset), Safety related activities of clinical studies (protocol, IB including RSI, ICF, CSR). Evaluation strategy, presentations and timely response to internal and external (other than Health Authority) requests e.g. legal, RDRC, medical information, business partners, affiliates). To take over activities of new medicinal product/device integration if applicable. Contributes to Technical Review Committee (TRC), Developmental Review Committee (DRC), NORSAP, if applicable and RDRC activities. The onboarding curriculum and/or materials for new staff. IT system selection, user requirements testing and providing user support, when requested. Tasks Under the general direction of the Therapeutic Area Lead, partners with cross functional teams to ensure efforts are aligned to meet global risk management strategies for assigned products. May chair the RMST, upon request TA lead, for assigned products and includes review of data analysis, review of presentation slide decks, review of RMST post meeting notes (PMN) and checking process compliance. Supports Clinical Development/Regulatory Affairs/Affiliates on ad hoc questions concerning medical / clinical safety (expert reports, regulatory dossiers). Ensures escalation of emerging safety issues or significant safety signals qualifying for urgent notification to Health Authorities are investigated in a timely manner and as per the urgent potential safety issue (UPSI) process. Ensures that patient risk reduction strategies are included in relevant documents such as clinical study protocols, study reports, informed consent forms and SmPC/Patient Leaflet before going to TRC/DRC. Involvement in the correct communication and information on drug safety topics, in particular drug safety review of promotional - and medical affairs material. Ensures in close collaboration with Clinical Operations and Clinical Development, the exchange of all safety relevant information between the Global Pharmacovigilance (GPV) Department Organon and involved CROs for all clinical development projects is organized. Responsible, in close collaboration with Clinical Operations and involved CROs, for the review/preparation of individual safety reports (incl. SUSARs) and reports of aggregated clinical data (Annual Safety Reports/Developmental Safety Update Reports) according to legally required timelines to Health Authorities, Ethical Committees and external Safety Review Boards. Oversees programs and registries safety related compliance, including the monitoring and follow-up of reports in special programs such as pregnancy registries, Patient support programs, market research, pre-license access programs, digital health solutions if appropriate. MedDRA updates for assigned products twice per year. Creation and/or maintenance of targeted questionnaires for assigned products. Projects on assignment. Qualifications/ Skills (professional and/or technical) Excellent Analytical skills, to evaluate, interpret, present and critically discuss safety data in internal as well as in external environment. Highly effective communication and influencing skills, able to present complex data to groups at all levels of the organization. Excellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations, GCP) and ability to interpret and apply global drug safety regulations. Good computer literacy with experience with safety databases and other IT systems (Argus preferably, MS office SharePoint, PowerPoint and Excel). Ability to prioritize tasks and consistently deliver on deadlines, with high standards for quality and sense of urgency. Fluency in English. Collaborative and team orientated; ability to set up and implement Drug Safety strategies, Risk Management Plans, develop Drug Safety systems and procedures, and elevate and resolve issues. 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. Sound knowledge and/or experience in other related disciplines is a plus, e.g., Pharmacoepidemiology, Pharmaceutical Medicine, Clinical Research, and/or experience in Clinical Pharmacology. Experience in Medical Device product quality regulations and safety monitoring is a plus. Experience in data analysis, signal detection and benefit/risk evaluation. Comprehensive knowledge of pharmacovigilance and clinical trial (ICH/GVP/GCP) legislations and the relevant Regulations governing Pharmacovigilance globally. Education / Certificates MD-degree with several years of clinical experience exercising medical judgment as a physician ideally specialist in Woman's Health, Internal medicine, or Pharmaceutical Medicine. Post-graduate qualifications in other areas are a plus. MD/PhD/MSc Equivalent with experience in International Drug Safety, ideally operational, post-marketing as well as clinical drug safety. #J-18808-Ljbffr