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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. **Overview of Job Role**The Director, Benefit Risk Management will be a high-impact leader, developing our Nästa 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.**Job requirements:****Education:** Master’s Degree in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences; advanced degree is preferred (e.g. PharmD., PhD.) **Experience:** 10+ years in Pharmacovigilance/Drug Safety with at least 5 years in a senior team leadership or supervisory role. experience with Veeva Platform Previous experience with biologic and combination products is an advantageDetailed knowledge of PV processes, directives, regulations and international guidelines (21 CFR, ICH, GVP, GCP, CIOMS, etc.)Mature self-organizational, time-management and interpersonal skills Excellent communication skills, maintains a positive, result oriented work environment* **Meaningful Work:** Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people’s lives.* **Global Growth:** Join a fast-growing, international Företag with a diverse and inclusive culture.* **Collaborative Environment:** Work in a positive, flexible, and innovative setting that values teamwork and creativity.* **Career Development:** Benefit from support for personal growth, internal mobility, and ongoing training opportunities.* **Cultural Exchange:** Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays.* **Well-being & Perks:** Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee.* **Community & Celebration:** Participate in regular social events and celebrate team milestones together.At Alvotech, we are building a global biotechnology Företag with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide. Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars. We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged. Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business. Whether you are at the start of your career or looking to take your Nästa step, Alvotech offers the opportunity to do work that matters, in a Företag driven by purpose and scale.If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide.If you have any technical issues, please contact: #J-18808-Ljbffr
Om tjänsten:
Företag: Alvotech
Tjänst: Director, Benefit Risk Management
Arbetsplats: Stockholms län
Land: SE
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