This individual contributor role at Moderna's Warsaw hub focuses on global safety surveillance operations. The person will be responsible for the end-to-end quality review, validation, and classification of safety and product quality data derived from Moderna-sponsored social media sites, social listening, and other monitored digital platforms. The role ensures rapid assessment, traceability, and communication of potential safety events, emphasizing acute attention to detail, strong pharmacovigilance acumen, and comfort with technology-based platforms, including emerging Generative AI tools for data capture and analysis. The position contributes to global health initiatives within a pioneering team revolutionizing medicine through mRNA technology.
Review social media and social listening data records to detect and validate reportable safety events and product quality complaints.,Perform quality checks to ensure accurate safety event classification, MedDRA coding, and appropriate product assignment.,Identify valid and invalid Individual Case Safety Reports (ICSRs) and Product Quality Complaints (PQCs).,Send timely safety and product quality notifications to relevant internal teams (Drug Safety and Product Quality).,Post due diligence messages to reporters on monitored platforms (as permitted) and ensure documentation of these interactions.,Route invalid ICSRs to internal dashboards to support broader signal detection activities.,Support reconciliation processes to confirm data completeness and traceability.,Escalate discrepancies, communication delays, or technical issues in data handling systems.,Contribute to the generation of process KPIs and metrics.,Assist in inspection readiness, process improvement initiatives, and maintenance of monitoring tools as needed.,Maintain documentation in alignment with Good Documentation Practices (GDP).,Support adjacent departmental initiatives and cross-functional collaborations when assigned.
University degree in Pharmacy/Medicine or other relevant life sciences discipline (Nursing, Experimental Medicine, Microbiology, Veterinary, Biotechnology, Physiotherapy, Medical Biology or similar).,Minimum 3 years' experience in Pharmacovigilance, Drug Safety, or Quality roles.,Experience with safety systems (e.g., MedDRA coding) preferred.,Strong knowledge of ICSR requirements, product quality complaint handling, and PV regulatory standards (ICH, EMA, FDA).,Proficiency in English (verbal and/or written) required due to global collaboration needs.,Familiarity with social media monitoring tools and digital platforms is desirable.
University degree in Pharmacy/Medicine or relevant life sciences discipline
Moderna is a biotechnology company pioneering a new class of medicines made of messenger RNA (mRNA). The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases.
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