Job Description 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). Key Responsibilities Leads signal detection, safety evaluation and risk management planning for low-medium complex medicinal products and/or medical devices during clinical development and/or for established brands. Leads Pharmacovigilance and Risk Management Planning and develops strategy for evaluation of issues in the clinical matrix. Leads safety contributions to global regulatory submissions. Ensures 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. Drives scientific safety assessment of individual development assets for effective benefit-risk decision-making. Accountable for: Signal management of assigned products, timely handling of signal evaluations and benefit/risk assessments. CCDS/CCSI and key local labels safety sections. Risk management planning (RMP) and Additional Risk Minimization Measures (ARMM) development and execution. Responsible for: Evaluation strategies and presentations, as well as adequate documentation. Creation of Aggregate Safety Reports (ASR) and Risk Management Plans (RMP). Safety related activities of clinical studies when applicable. Timely response to internal and external requests. Integration activities of new medicinal products/devices if applicable. Contributes to: Technical Review Committee (TRC), Developmental Review Committee (DRC), and other activities. Onboarding curriculum and materials for new staff. IT system selection and user support when requested. Qualifications/Skills: Excellent analytical skills to evaluate and present safety data. Highly effective communication and influencing skills. Excellent knowledge of international regulations and ability to apply them. Good computer literacy with experience in safety databases and IT systems. Ability to prioritize tasks and deliver on deadlines. Fluency in English. Collaborative and team-oriented. Experience: 3-5 years of PV experience in the pharmaceutical industry. Expert knowledge in pharmacovigilance and methodologies. Sound knowledge of the therapeutic area of assigned products. Experience in data analysis, signal detection and benefit/risk evaluation. Education/Certificates: MD-degree with clinical experience, ideally in Woman's Health or related fields. MD/PhD/MSc Equivalent with experience in International Drug Safety. #J-18808-Ljbffr