Bogota PV Affiliate, Drug Safety Associate, Colombia

Job description

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com . Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. Working Environment and Location This position is based in Bogotá D.C. and will require on-site work in a hybrid set up. At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Purpose and Scope In coordination with the RAPV Affiliate Lead and Drug Safety Officer (DSO): This function is responsible for aspects of excellence in Pharmacovigilance (PV) activities at the local affiliate. Reports to RAPV Affiliate Team Lead Colombia. Contributes to the successful execution of the local PV objectives supporting the overall PV mission. Responsible for acting as the back-up of the local Drug Safety Officer (DSO) and manage its related duties. Act as the deputy of the local qualified person for PV (if applicable). Executes procedures to ensure compliance with both local and regional PV regulations and Astellas global and regional policies and procedures. Performs local case intake and processing tasks and relevant activities for the Drug Safety department of the local affiliate, to support and ensure monitoring and review of PV activities and aspects of the local PV system. Local case intake activities are directly impacting Astellas’ compliance. In addition, this function is to implement process improvements at a local affiliate level. The function is in contact with Astellas customer e.g., patients and health care professionals using Astellas’ products, and interfaces with Astellas local Clinical Operations, Regulatory Affairs, Medical Affairs, Marketing, Sales and other business units as well as with the RAPV Headquarter functions. Responsible for managing safety information from all incoming sources such as the PV mailboxes to ensure emails are dealt with in a time appropriate manner. Role and Responsibilities ICSR Case intake and local process Manage contacts of external and internal customers in matters relating to drug safety, ensuring that a professional, approachable and informative impression is given at all times. Supports with the coordination of the PV vendor to ensure timely intake/submissions of ICSRs. Process spontaneous product safety information from various sources (e.g, medical information, competent authorities, literature) according to relevant processes and standards, using the Global Safety Database (GSD). Perform local literature review, if applicable. Ensure correct use and entry of data in the GSD. Ensure timelines are met for each activity to ensure compliance, and monitoring at an affiliate level. Local PV Quality Management System Maintain appropriate logs and databases as necessary for optimal functioning and oversight of the local PV department. Support with writing and updating of local PV processes and standards. Support the RAPV affiliate lead/Drug Safety Officer (DSO) with internal and external PV-related correspondence. Execute routine reconciliations of various databases and with PV partners. Perform routine quality checks on the Out of hours availability at the affiliate according to relevant processes and standards. Support the implementation of PV Agreements and PV contracts with local vendors. Continue:Role and Responsibilities Ensure correct filing (electronically and hard copy) and archiving of related documents according to Good Documentation Practices. Update and maintain local Quality Documents (QDs) as required. Take part in special PV projects as and when needed upon assignment by RAPV affiliate Lead. May represent the local PV department in inspections and audits. Support with PV health authority inspections and audits. Support in monitoring local case submission compliance and take the necessary corrective and/or preventive actions locally for late reporting. Support in reporting compliance and other PV-related information as requested by RAPV Affiliate Management. Follow the business continuity plan for e.g., system failure and disasters in relation to PV activities. Participate in the 24/7 availability to enable appropriate handling of potential urgent safety issues by the affiliate. People and Organization Management Guides junior colleagues or vendor staff and/or oversees and controls local PV activities. Performs local PV training as needed. Responsible for the development and maintenance of effective collaborations with peers and internal PV key stakeholders and functions as well as relevant other stakeholders: With Health care professionals and consumers using Astellas’ products. With RAPV Affiliate Lead or DSO, other local interfaces e.g. Clinical Operations, Regulatory Affairs, Medical Affairs, Quality Assurance Marketing, Sales, Ethics and Compliance and other business functions. With RAPV HQ and/or Affiliate Management Team Members Essential Qualifications Minimum BA/BS, Degree in Health Science, Life Science or Medical Science. Minimum of 2 years relevant experience in pharmacovigilance or combines PV/RA/QA and/or clinical development. Good knowledge and understanding of local PV requirements and guidelines of the assigned country or countries. Good knowledge of regulatory requirements and is able to translate regulations into business requirements. A technical expert with an in-depth understanding of aspects of the local PV system and knowledge of related disciplines. Has a very strong industry perspective. Excellent time-management and proven organizational skills. Fluent in written and spoken business English and Spanish. Benefits Careers | Astellas Why Astellas Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day. Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare. A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions. Our Organizational Values and Behaviors Values: Integrity, Innovation and Impact sit at the heart of what we do. Behaviors: We come together as ‘One Astellas’ , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution. Apply now » Apply Now Start applying with LinkedIn Please wait... Find similar jobs: