Description

About the Department/Company <div><div>Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines. </div><div>Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities. </div><div>iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position: </div><div> </div><div>Overview of Job Role </div><div>The Director, Benefit Risk Management will be a high-impact leader, developing our next generation pharmacovigilance benefit risk management infrastructure. This is a rare opportunity within a global biosimilar leader to build a specialized Benefit Risk Management team from ground up, moving beyond traditional Benefit-Risk and Periodic reporting activities to a strategic and lean data-driven approach using a state-of-the-art Safety database systems. You will be fully accountable for the integrity and strategy of all Signal and Risk management, Periodic reporting and Regulatory intelligence activities for the product lifecycle — from clinical trials to post-marketing surveillance. This role is about building a lean and efficient team, defining the team’s processes, owning the deliverables and ensuring regulatory compliance. </div><div>Scope and responsibility:</div><div><ul><li>Recruit, mentor, and lead a high-performing Global Benefit Risk Management team, fostering a culture of scientific excellence and regulatory agility. </li></ul></div><div><ul><li>Drive the strategy for Signal management, Benefit-Risk monitoring, Safety aggregate reporting and Regulatory Intelligence for company clinical trials as well as post-marketing programs </li></ul></div><div><ul><li>Business owner of Safety systems and processes to execute the activities (SME), system setup and lifecycle management (e.g. configuration, validation, system lifecycle management, etc.) </li></ul></div><div><ul><li>Establish, maintain and optimize Global Pharmacovigilance system processes and ensure compliance with international law and regulations (e.g. FDA, EMA, ICH). </li></ul></div><div><ul><li>Work cross-functionally with other PV department teams and to align on resources, timelines and deliverables for Benefit Risk Management team and ensure executions and submission compliance. </li></ul></div><div><ul><li>Work cross-functionally with other teams and departments in the company (e.g. Quality, Regulatory, Medical affairs, etc.) and also externally with PV service providers and Business partners. </li></ul></div><div><ul><li>Audits and Inspections deliverables related to Benefit Risk Management activities </li></ul></div><div> </div></div><div><div>Job requirements:</div><div><ul><li>Education: Master’s Degree in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences; advanced degree is preferred (e.g. PharmD., PhD.) </li></ul></div><div><ul><li>Experience: 10+ years in Pharmacovigilance/Drug Safety with at least 5 years in a senior team leadership or supervisory role. </li></ul></div><div><ul><li>Deep expertise in Benefit Risk management activities and Safety systems (e.g., Argus, ARISg) including CSV and lifecycle management activities; previous experience with Veeva Platform (e.g. Safety Vault/Safety Docs) is great advantage </li></ul></div><div><ul><li>Proven track record of management of PV teams and global Product and Study portfolios </li></ul></div><div><ul><li>Previous experience with biologic and combination products is an advantage </li></ul></div><div><ul><li>Detailed knowledge of PV processes, directives, regulations and international guidelines (21 CFR, ICH, GVP, GCP, CIOMS, etc.) </li></ul></div><div><ul><li>Mature self-organizational, time-management and interpersonal skills </li></ul></div><div><ul><li>Excellent communication skills, maintains a positive, result oriented work environment </li></ul></div><div><ul><li>Able to work independently, plan, organize and deliver, and feel comfortable in a multicultural team. </li></ul></div><div><ul><li>Willingness to travel internationally, as required </li></ul></div></div>What we offer:<ul><li>Meaningful Work: Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people’s lives.</li><li>Global Growth: Join a fast-growing, international company with a diverse and inclusive culture.</li><li>Collaborative Environment: Work in a positive, flexible, and innovative setting that values teamwork and creativity.</li><li>Career Development: Benefit from support for personal growth, internal mobility, and ongoing training opportunities.</li><li>Cultural Exchange: Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays.</li><li>Well-being & Perks: Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee.</li><li>Community & Celebration: Participate in regular social events and celebrate team milestones together.</li></ul>

Director, Benefit Risk Management

Description

Alvotech

Pipeline