Director, Benefit Risk Management

Om jobbet

About the Department/Company

Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines.

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.

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:

Overview of Job Role

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.

Scope and responsibility:

• Recruit, mentor, and lead a high-performing Global Benefit Risk Management team, fostering a culture of scientific excellence and regulatory agility.

• 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

• 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.)

• Establish, maintain and optimize Global Pharmacovigilance system processes and ensure compliance with international law and regulations (e.g. FDA, EMA, ICH).

• 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.

• 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.

• Audits and Inspections deliverables related to Benefit Risk Management activities

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.

• 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

• Proven track record of management of PV teams and global Product and Study portfolios

• Previous experience with biologic and combination products is an advantage

• Detailed 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

• Able to work independently, plan, organize and deliver, and feel comfortable in a multicultural team.

• Willingness to travel internationally, as required

What we offer:

• 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 company 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.