4 Pharmacovigilance Processes Jobs

As an experienced Veeva Vault Safety Consultant, you will be responsible for supporting the implementation, migration, and optimization of Veeva Vault Safety solutions. Your expertise in Veeva Vault Safety, coupled with a solid understanding of pharmacovigilance processes and regulatory compliance within the life sciences industry, will be crucial for this role. Your key responsibilities will include leading and actively participating in Veeva Vault Safety implementation, configuration, and customization projects. You will collaborate with stakeholders to gather business requirements and effectively translate them into functional solutions. Additionally, you will support migration assessments and executions from legacy safety systems to Veeva Vault Safety, providing ongoing system enhancements, troubleshooting, and user support. Ensuring compliance with regulatory requirements such as GVP, FDA, and EMA in pharmacovigilance workflows will be a critical aspect of your role. Working closely with cross-functional teams, including IT, business analysts, and quality assurance, you will contribute to the successful delivery of solutions. Furthermore, you will be responsible for developing and maintaining documentation, including user guides and training materials, while staying updated with Veeva product updates and industry best practices. To excel in this role, you should possess a minimum of 3-5 years of experience in Veeva Vault Safety or similar pharmacovigilance solutions. Hands-on experience with Veeva Vault Safety configuration, workflows, and data migration is essential. A strong understanding of pharmacovigilance processes, safety case management, and regulatory requirements is also required. Your analytical thinking skills will be valuable for assessing business needs and recommending optimal solutions. Excellent verbal and written communication skills are crucial, enabling you to effectively collaborate with stakeholders across different levels. While a Veeva Vault Safety certification is preferred, it is not mandatory for this role.,

You are a dynamic and results-oriented Business Development Manager tasked with driving growth in the Pharmacovigilance services sector, with a specific focus on integrating Artificial Intelligence (AI) solutions. Your role requires a strong understanding of pharmacovigilance processes, regulatory compliance, and AI-driven innovations, along with a successful track record in business development and client relationship management within the life sciences industry. Your responsibilities will include strategic growth development, where you will identify, evaluate, and pursue new business opportunities in pharmacovigilance, including AI-powered solutions. You will also be responsible for developing and implementing strategies to expand the company's market presence and client portfolio. Client engagement is a key aspect of your role, involving building and maintaining long-term relationships with pharmaceutical companies, biotech firms, and regulatory agencies. You will need to understand client needs and propose tailored PV and AI solutions to meet their requirements. Promoting AI integration in PV services is another critical responsibility, where you will advocate for AI-driven tools and solutions for adverse event reporting, signal detection, and risk management. Staying updated on emerging AI trends and translating them into business opportunities will be essential. Collaboration with cross-functional teams, including technical experts in pharmacovigilance, AI, and data science, is necessary to develop customized service offerings. Additionally, collaborating with the marketing team to create compelling proposals, presentations, and campaigns will be part of your role. Market analysis and competitive intelligence activities are required to conduct market research, identify trends, competitive landscapes, and emerging needs in PV and AI. Leveraging insights from this analysis to refine business strategies and solutions will be crucial. Revenue growth and KPI achievement are fundamental to your role, where achieving revenue and sales targets through consistent business development efforts is expected. Monitoring and reporting on sales performance and market dynamics will also be part of your responsibilities. Your qualifications should include a Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, or a related field, with an advanced degree (MBA, MPH, or MSc) preferred. You should have at least 5 years of experience in business development within pharmacovigilance, life sciences, or healthcare, with hands-on experience in AI tools or services applied to PV being highly desirable. Skills and competencies required for this role include a deep understanding of pharmacovigilance processes, regulations (e.g., FDA, EMA, ICH guidelines), and compliance standards. Familiarity with AI applications such as natural language processing, machine learning, and automation in pharmacovigilance is essential. Excellent communication, negotiation, and presentation skills, along with the ability to work in a fast-paced, goal-oriented environment, are also necessary. Preferred certifications for this role include certification in pharmacovigilance (e.g., Advanced Pharmacovigilance by DIA) or AI-related courses. In return, we offer a competitive salary and performance-based incentives, along with the opportunity to work with cutting-edge technologies in PV and AI within a collaborative and inclusive work environment.,

The PV Scientist Manager is responsible for contributing to the planning, preparation, writing, and review of non-medical portions of aggregate reports. Collaborating with affiliates and other internal Amgen partners, the PV Scientist Manager ensures timely deliverables. Additionally, reviewing Adverse Events/Serious Adverse Events from clinical trials is part of the role. Under the guidance of the Global PV Sr. Scientist or Lead, the PV Scientist Manager reviews study protocols, statistical analysis plans, and other clinical study-related documents. They provide input on the design of safety data tables, figures, and listings from clinical studies. Participation in the development of safety-related data collection forms, attending study team meetings, and conducting signal detection, evaluation, and management are key responsibilities. The PV Scientist Manager performs data analysis to evaluate safety signals, collaborates with the Global Safety Organization (GSO) on analysis results, and prepares safety assessment reports and other safety documents. They search and review adverse event data and relevant literature for signal detection purposes, participate in Safety Governance processes, and prepare presentations on safety recommendations for decision-making bodies. Assisting in the development of risk management strategies, providing content for risk management plans, updating regional risk management plans, overseeing risk minimization activities, and preparing responses to regulatory inquiries related to risk management plans are critical tasks. Supporting activities related to new drug applications and regulatory filings, contributing to safety-related regulatory strategies, and assisting in developing safety-related regulatory activities are also part of the role. In terms of Inspection Readiness, the PV Scientist Manager undertakes activities as delegated by the QPPV, maintains a state of inspection readiness, and acts as a representative and point of contact for Health Authority Inspections and Internal Process Audits within their role and responsibilities. Contributing to the Global Patient Safety (GPS) team, the PV Scientist Manager assists in developing, improving, and standardizing pharmacovigilance processes and methods. They also participate in teams for implementing new processes and methods within the Therapeutic Area. Basic Qualifications and Experience: - Masters or Bachelor's degree in a relevant field - Minimum of 9+ years of experience The PV Scientist Manager's role encompasses a wide range of responsibilities in pharmacovigilance, risk management, regulatory activities, and inspection readiness, contributing significantly to the safety and effectiveness of pharmaceutical products.,

The Global Safety Therapeutic Areas at Amgen serve as the safety experts for all Amgen products globally. They are responsible for defining the safety strategy and major safety deliverables for each Amgen product. As a leader in the therapeutic area safety teams, you will oversee staff management and resource allocations in Global Patient Safety. Your role will involve supporting GPS in establishing a highly effective global safety organization that complies with worldwide regulations. As a Global PV Sr. Scientist, you will collaborate with the Therapeutic Safety Teams on safety assessment activities related to medical and scientific operations. Additionally, you will provide scientific and compliance expertise to GPS as required. Your responsibilities as a Global PV Sr. Scientist include directing the planning, preparation, writing, and review of portions of aggregate reports. You will also coordinate liaison activities with affiliates and other internal partners at Amgen regarding products. Furthermore, you will provide oversight to staff on safety in clinical trials, review study protocols, statistical analysis plans, clinical study-related documents, adverse events, and safety data from clinical studies. You will be involved in signal detection, evaluation, and management, performing data analysis for safety signals, documenting work in the safety information management system, authoring Safety Assessment Reports, and collaborating with the GSO on safety documents and regulatory responses. Additionally, you will support risk management activities, prepare responses to regulatory inquiries, and contribute to new drug applications and other regulatory filings. In terms of inspection readiness, you will undertake activities delegated by the QPPV as outlined in the PV System Master File and maintain a state of inspection readiness. You will also serve as a representative and point of contact for Health Authority Inspections and Internal Process Audits within your role and responsibility. Your knowledge and skills should encompass a range of areas including pharmacovigilance regulations, drug development, safety data capture, safety database structure, MedDRA, safety data analysis, risk management, and product knowledge. You should also possess intermediate skills in various pharmacovigilance processes, document writing, risk management plans, statistical methods, biomedical literature review, organization, collaboration, critical assessment, scientific writing, and communication. A strong background in pharmacovigilance, expertise in defined subject areas, problem-solving abilities, autonomy in executing strategies, and a contribution to business results through quality and leadership are essential. Your education should include a Doctorate/Masters degree/Bachelors degree with 12 to 17 years of directly related experience, preferably in Life Sciences with managerial experience and clinical/medical research expertise in a biotech/pharmaceutical/CRO setting.,