Director, Safety Data 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, Safety Data Management will be a high-impact leader developing our next-generation safety data management infrastructure. This is a rare opportunity within a global biosimilar leader to build a specialized Safety Data Management team from ground up, moving beyond traditional case processing to a strategic, lean and data-driven approach using a state-of-the-art Safety database systems. You will be fully accountable for the integrity and strategy of all safety data across the product lifecycle - from clinical trials to post-marketing surveillance. This role is about building a lean and efficient team, defining processes, owning the deliverables and ensuring regulatory compliance.

Scope and responsibility

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

• Drive the strategy for safety data management activites for both clinical trials and post-marketing (e.g. ICSR/SAE management, Regulatory submissions, Literature monitoring, Digital platform monitoring, Reconciliations, EV, XEVMPD, etc.)

• Business owner of Company safety database (SME), system setup and lifecycle management in cooperation with company QA and IT functions (e.g. system configurations, validations, change management, setup of new Products and Clinical Studies, business partners, reporting rules, 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 to align on resources, timelines and deliverables to support all Clinica trials and Postmarketing programs activities

• 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 Safety Data Management activities

Job requirements

• Education: Master's Degree in pharmaceutical sciences or related fields - medicine, pharmacy, life sciences; advanced degree is preferred (PharmD., PhD.)

• Experience: 10+ years in Pharmacovigilance/Drug Safety with at least 5 years in a senior team leadership or supervisory role.

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

• Deep expertise in Safety data management activities and safety databases (e.g., Argus, ARISg), CSV and lifecycle management activities; previous experience with Veeva Platform Veeva Platform (e.g. Safety Vault/Safety Docs) is great advantage

• 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.