Senior Scientist, Pharmacovigilance

Specifics of the role:

• Manage and oversee Clinical trial safety activities and documents preparation and management (e.g. SMP, Protocol, eTMF, IB, etc.) for Alvotech Clinical trials

• Involved in Safety systems setup and lifecycle management (e.g. configuration, validation, system lifecycle management, etc.) to execute the assigned activities (SME)

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

• Work cross-functionally with other PV department teams and other teams (e.g. Medical affairs) to gather inputs for assigned clinical trial deliverables (e.g. SMP, Protocol, eTMF, IB, etc.) and ensure on-time delivery and compliance.

• Work cross-functionally with other teams and departments in the company (e.g. Quality, Regulatory, IT, CPD, etc.) and externally with PV service providers and Business partners

• Deliver trainings on pharmacovigilance processes and standards to company staff and external parties

• Involved in Audits and Inspections related to Benefit Risk Management activities

Minimum education and experience required for the role:

• Education: Master’s Degree in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences

• Experience: 4+ years in Pharmacovigilance/Drug Safety in similar functions with demonstrable hands on experience

• Hands-on experience in clinical trial safety activities

• Expertise in Safety systems (e.g., Argus, ARISg); previous experience with Veeva Platform (e.g. Safety Vault/Safety Docs) is great advantage

• Proven track record with 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

Key responsibilities and minimum requirements according to job level:

• Works and operates independently on assignments

• Performs both routine tasks within procedures and processes and non-routine tasks.

• Takes part in large projects.

• Challenges and decisions are discussed, made and solved in cooperation with supervisor/other employees.

• Can make adjustments/changes to procedures, processes and projects.

• Can have financial impact through decision making.

• Expert knowledge within field of expertise such as methods, techniques and equipment as well as relevant procedural/process knowledge.

• Is often advisory to other less experienced employees.

• Collaborates with supervisor and peers on complex decisions.

• Does not supervise staff.

Competencies required to fulfill the employee responsibilities and work assignments:

• An employee shall follow the job description that pertains to the position. In addition, an employee shall follow the SOPs that pertains to the position.

• An employee shall adhere to the company policies and procedures that are available on the Alvotech intranet – Alvocado.

About Us

At Alvotech, we are building a global biotechnology company 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 next step, Alvotech offers the opportunity to do work that matters, in a company 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: hr@alvotech.com