Warsaw, Mazowieckie, Poland
• Conduct internal audits and audits of business partners to assess compliance with pharmacovigilance procedures, regulations, and quality standards • Prepare comprehensive audit documentation, including audit reports and Corrective and Preventive Action (CAPA) plans, to address identified deficiencies • Coordinate the implementation of CAPA plans to ensure timely resolution of compliance issues and continuous improvement • Develop and update Standard Operating Procedures (SOPs) related to pharmacovigilance processes • Support the implementation of pharmacovigilance processes to ensure compliance with procedures, national and international regulations, and guidelines for the safety management of medicinal products and medical devices • Provide operational support for the quality management system in pharmacovigilance processes, including the development and maintenance of policies, procedures, and systems in accordance with applicable laws and organizational policies • Perform quality control activities in pharmacovigilance processes, implementing guidelines and collaborating with relevant departments to establish clear policies, procedures, instructions, forms, and objectives • Conduct and monitor pharmacovigilance training within the organization and contribute to the professional development of team members • Analyze pharmacovigilance data scientifically and provide expert knowledge in the field of medicine to offer substantive support to healthcare professionals and patients • Focus on preventing harm resulting from adverse reactions to authorized medicinal products, ensuring patient safety remains a top priority • Promote the safe and effective use of medicinal products by providing timely and relevant safety information to patients, healthcare professionals, and other stakeholders • Manage the purchase of documentation, certificates, quality standards, and training materials, as well as systems supporting training management
1. Case Processing: • Review and process adverse event reports and other safety-related information received from healthcare professionals, patients, and other sources. • Conduct thorough evaluations of individual case safety reports (ICSRs) to assess potential risks and benefits associated with the use of our products. • Follow regulatory guidelines and internal procedures to accurately document and report adverse events in compliance with safety reporting requirements. 2. Medical Literature Screening: • Perform systematic literature reviews to identify relevant safety information related to our products. • Analyze and evaluate scientific articles and publications to assess any potential safety signals or emerging risks. • Collaborate with medical experts to interpret literature findings and contribute to pharmacovigilance decision-making. 3. Medical Inquiries Handling: • Respond to medical inquiries from healthcare professionals and consumers regarding the safety and appropriate use of our products. • Provide accurate and up-to-date safety information to address inquiries effectively. • Document and track medical inquiries and responses in a comprehensive manner. 4. Risk Management Plan (RMP) and Periodic Safety Update Report (PSUR) Documentation: • Assist in the preparation and maintenance of Risk Management Plans (RMPs) to ensure proactive risk minimization strategies are in place. • Contribute to the compilation of Periodic Safety Update Reports (PSURs) summarizing the safety profile of our products. • Collaborate with cross-functional teams to gather necessary safety data and information for RMP and PSUR submissions to regulatory authorities.
Handling adverse events, medical enquiry, product enquiry, product quality complaints received from HCPs/Customers/affiliates/business partners through telephone, letter, fax, e-mail, sales representative or other company personnel, in accordance with company’s controlled documents. Logging and updating of enquiry in Medical Information database. Preparation and communication of enquiry response in liaise with designated medical reviewer. Assist designated medical reviewer for follow-up of all medical enquiry. Reconciliation of medical enquires in accordance with Safety Data Exchange Agreements and company’s controlled documents.
Support of administrative activities for regulatory affairs and pharmacovigilance. Verification of translations of texts and graphic projects for the medicinal product. Preparation of reports concerning medicinal products based on public databases. Screening of medical literature. Archival of clinical and nonclinical documentation for medicinal products.
Designed physical therapy programs individualized to meet children’s specific needs, with particular focus on cerebral palsy and other neurological disorders. Liaised international communication between the company and the equipment producer Hocoma. Provided training to new employees. Worked one-on-one with children. Provided education to parents about athome exercises to do with children. Completed all medical documentation for provided paediatric physical therapy. Provided advanced Lokomat therapy to children.