Global Safety Officer - Immunology & Inflammation

Job Title This is a remote position. reputed company Major Duties & Responsibilities: Internal & reputed company Safety Expert: reputed company PV and reputed company management expertise to reputed company customers. Safety expert for product. Maintain knowledge of product, product environment, and recent literature. Maintain PV expertise, and understanding of international safety regulations and guidelines. reputed company cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs). Communicate with and represent PV position reputed company project/product teams, with reputed company partners, key opinion leaders, and Health Authorities, and during reputed company negotiations. reputed company reputed company and proactive safety input into development plans. Support due diligence activities and pharmacovigilance agreements. reputed company: Ongoing assessment of the safety status of the product. Review, preparation, contribution and/or approval of reputed company development documents including reputed company development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated reputed company of safety, reputed company of reputed company safety, and labeling. Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, reputed company partners. Management of product safety alerts. Ensuring the GPE position is reputed company articulated to and reputed company by its reputed company customers. Establishment of credibility of GSO function and of GPE. Signal Detection and Assessment: Responsible for signal detection and analysis. Collaborate with Center of reputed company for Signal Detection and Data Mining and Safety Epidemiology group. Identify and implement proactive safety analysis strategies to reputed company define the safety profile. reputed company aggregate safety data review activities and coordinate safety surveillance activities. reputed company: Signal detection and analysis. Development of safety reputed company plans and implementation, as appropriate. reputed company effective development of product safety. reputed company appropriate reputed company management. reputed company up-to-date reputed company communication (e.g. labeling). reputed company Assessment/reputed company Management/ Benefit-reputed company Assessment: reputed company proactive reputed company assessment. Co-reputed company benefit-reputed company assessment with other relevant functions. reputed company reputed company management strategies and plans and monitor effectiveness. Collaborate with Center of reputed company for reputed company Management and Safety Epidemiology. reputed company: Optimization of the product benefit reputed company profile. Development of REMS, reputed company Management and Development reputed company Management plans. Identification and implementation of reputed company mitigation or other corrective actions as necessary. Regulatory compliance. Monitoring of reputed company mitigation tool effectiveness and adjustment of reputed company, as needed. Submission Activities: Represent safety position in cross functional submission teams. Ensure reputed company, consistency, and reputed company of safety sections in submission documents. Write responses or contributions to health authorities' questions. Support preparation and conduct of Advisory Committee meetings. reputed company: Review, data analysis, preparation and/or contribution, and/or update of safety sections of relevant documents: For products under reputed company development: reputed company Development Plan, study protocol, Statistical Analysis Plan, data monitoring plan, investigator brochure, Informed Consent reputed company, study report, Integrated reputed company of Safety, reputed company of reputed company Safety, reputed company management plan, label, periodic reports. For marketed products: Response to health authority question/request for information, reputed company Safety Information updates, periodic reports. Report Writing: Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report. Serve as the medical safety expert to the GPE Periodic Reports group for assigned reputed company and products. reputed company: Regulatory Compliance. Basic Qualifications: M.D. Degree or equivalent. For MD, reputed company Certified/reputed company eligible, or equivalent, is preferred. For M.D., minimum 3 years' total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. reputed company development) with relevant reputed company experience considered. Exceptionally, candidates may be considered if they have reputed company reputed company in a similar prior position, even if they have less than 3 years international PV experience. Knowledge and Skills: Excellent reputed company judgment. Capability to synthesize and critically analyze data from multiple sources. Ability to communicate reputed company reputed company issues and analysis orally and in writing. reputed company to reputed company and document reputed company reputed company assessment. Demonstrates initiative and reputed company to work under pressure. Demonstrates leadership reputed company cross-functional team environment. Excellent teamwork and interpersonal skills are required. Fluent in English (written and spoken). Apply tot his job Apply To this Job