Alvotech is seeking a dynamic and experienced Risk Lead to join our innovative Combination Products and Devices team. In this role, you will lead the compilation of risk management files for Alvotech combination products, ensuring compliance with international standards. You will collaborate with medical experts and external participants to gather specialist input, particularly in the evaluation of harms for risk management documentation. Additionally, you will be responsible for developing and maintaining Alvotech procedures aligned with global medical device risk management regulations. Your work will also involve conducting timely reviews and updates to risk management files based on periodic evaluations or product-related complaints. A key part of your role will be training others in risk management, equipping them with the necessary knowledge and skills to uphold safety and compliance standards.
Key Responsibilities:
- Risk Management File Compilation – Lead the creation and organization of risk management files for Alvotech combination products.
- Expert Collaboration – Liaise with medical professionals and external participants to collect specialist input, particularly on harm evaluation.
- Procedure Development – Establish and refine Alvotech risk management procedures in alignment with international medical device standards.
- File Reviews & Updates – Ensure timely review and modification of risk management files based on periodic assessments or market complaints.
- Training & Knowledge Sharing – Provide training to others in risk management, fostering expertise across teams.
Qualifications:
- Master’s Degree with at least 5 years of relevant experience.
- Strong leadership and strategic planning skills.
- Excellent decision-making and problem-solving abilities.
- High level of independence and accountability.
- Broad knowledge of the pharmaceutical value chain.
- Experience with internal and external stakeholder engagement.
- Ambitious, proactive, and hands-on approach.
- Strong team player with a collaborative mindset.
- Excellent verbal and written English communication skills.
- Service mindset.
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
Why Alvotech
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.
Your Application
We look forward to your application! Please send your application as soon as possible, as the position may be filled immediately.
For any questions regarding the role, please contact Jessica Keränen, Search Partner at Capa Interim & Recruitment, at jessica.keranen@capa.se