Risk Lead

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.

We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.

We encourage you to visit our Career page (link: Join us - Alvotech - Better Access Better Lives) It offers valuable insights into our culture, values, and the innovative work we do.

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.