Senior Drug Safety Specialist - Pharmacovigilance

Why This Role Matters

Pharmacovigilance is a critical function in the pharmaceutical and biopharmaceutical industry, ensuring that medicines remain safe and effective throughout their lifecycle. From clinical trials to post-marketing surveillance, pharmacovigilance professionals monitor adverse events, analyze safety data, and ensure regulatory compliance with international drug safety standards.
The Senior Pharmacovigilance Specialist role at Alvotech is essential in maintaining the safety profile of biosimilar medicines and supporting global safety operations. The position focuses on safety data management for clinical trials and post-marketing programs while ensuring that pharmacovigilance activities meet international regulatory requirements. As part of the Global Safety Data Management team, the Senior PV Specialist will contribute to safety data analysis, adverse event reporting, regulatory submissions, and the development of pharmacovigilance processes and systems. The role also supports safety system lifecycle management and cross-functional collaboration with clinical, regulatory, and quality teams.
This position provides experienced pharmacovigilance professionals with the opportunity to work on global drug safety programs while contributing to the development and monitoring of biosimilar medicines.

Job Description

Alvotech is seeking a skilled Senior Pharmacovigilance Specialist to support clinical safety and post-marketing pharmacovigilance activities within its Research and Development function. The selected candidate will join the Global Safety Data Management team and will be responsible for managing safety data related to clinical trials and marketed products. The role involves overseeing adverse event reporting, maintaining safety databases, ensuring regulatory compliance, and supporting the development of pharmacovigilance systems and processes.
The Senior PV Specialist will also collaborate with cross-functional teams across the organization to ensure that safety activities are performed efficiently and in compliance with global pharmacovigilance standards.

Key Features of the Role

• Opportunity to work in global pharmacovigilance and safety data management
• Involvement in clinical trial safety monitoring and post-marketing surveillance
• Participation in pharmacovigilance system configuration and lifecycle management
• Collaboration with global regulatory, quality, and clinical teams
• Contribution to safety process optimization and regulatory compliance initiatives
• Exposure to safety monitoring for biosimilar medicines

Responsibilities

Clinical Safety & Pharmacovigilance Activities

• Manage assigned clinical safety and post-marketing pharmacovigilance activities
• Handle Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) processing
• Support regulatory safety submissions and reporting requirements
• Conduct literature monitoring and digital platform monitoring for safety signals
• Perform pharmacovigilance reconciliations and safety data reviews
• Support activities related to EudraVigilance and XEVMPD

Safety Systems & Data Management

• Participate in configuration, validation, and lifecycle management of pharmacovigilance systems
• Maintain and monitor safety databases to ensure data accuracy and regulatory compliance
• Work with safety systems such as Oracle Argus Safety, ARISg Safety System, and Veeva Vault Safety

Pharmacovigilance Process Management

• Create, maintain, and optimize global pharmacovigilance processes
• Ensure compliance with international regulatory guidelines and company procedures
• Monitor pharmacovigilance activities to maintain regulatory compliance across clinical and post-marketing programs

Cross-Functional Collaboration

• Work closely with pharmacovigilance teams involved in benefit-risk management and clinical trials
• Collaborate with departments such as Quality, Regulatory Affairs, IT, and Clinical Program Development
• Coordinate with external pharmacovigilance service providers and business partners

Training, Audits & Compliance

• Deliver pharmacovigilance training programs to internal staff and external partners
• Participate in safety-related audits and regulatory inspections
• Ensure proper documentation and compliance with global pharmacovigilance standards

Required Qualifications

Educational Requirements

• Master’s degree in Pharmaceutical Sciences, Pharmacy, Medicine, or Life Sciences

Experience and Skills

• Minimum 5 years of experience in Pharmacovigilance or Drug Safety
• Strong experience in safety data management functions
• Hands-on experience in clinical trial safety and post-marketing pharmacovigilance activities
• Experience working with global pharmaceutical products and clinical trials
• Familiarity with biologic or combination products is considered an advantage

Technical Knowledge

• Experience working with pharmacovigilance safety systems such as Oracle Argus Safety, ARISg Safety System, or Veeva Vault Safety
• Understanding of global pharmacovigilance regulations including
• ICH Guidelines
• FDA Regulations
• Good Pharmacovigilance Practices
• Good Clinical Practice
• Council for International Organizations of Medical Sciences safety reporting standards

Professional Skills

• Strong analytical, organizational, and time-management skills
• Excellent communication and stakeholder management abilities
• Ability to work independently and manage complex pharmacovigilance activities
• Comfortable working in global and multicultural teams

Salary Insights

Although the salary package has not been specified, Senior Pharmacovigilance Specialist roles in the global biopharmaceutical industry typically offer competitive compensation based on experience, expertise, and geographic location.
Additional benefits may include international project exposure, professional development opportunities, and involvement in global clinical safety programs.

Company Overview

Alvotech is a global specialty biopharmaceutical company dedicated to developing and manufacturing high-quality biosimilar medicines.
The company focuses exclusively on biosimilars with the goal of improving access to biologic treatments while maintaining strict regulatory and quality standards. Within the Research and Development function, the Integrated Clinical and Medical Research department develops clinical strategies aligned with biosimilar regulatory guidelines and health authority requirements. Through advanced safety monitoring systems and global pharmacovigilance operations, Alvotech ensures the safety, effectiveness, and regulatory compliance of its products worldwide.

FAQs

Who can apply for this role?
Candidates with a Master’s degree in Pharmacy, Life Sciences, or Medicine and at least 5 years of pharmacovigilance experience.

What type of work does the Senior PV Specialist perform?
The role includes adverse event management, safety data analysis, regulatory reporting, safety system management, and pharmacovigilance compliance activities.

Is experience with safety databases required?
Yes. Experience with systems such as Argus, ARISg, or Veeva Vault Safety is preferred.

Does the role involve working with clinical trials?
Yes. The position supports safety monitoring for both clinical trials and post-marketing pharmacovigilance programs.

Application Tips

• Highlight your pharmacovigilance and safety data management experience
• Mention expertise in ICSR processing, SAE reporting, and regulatory submissions
• Include knowledge of safety databases such as Argus or Veeva Vault Safety
• Demonstrate familiarity with global PV regulations such as ICH, GVP, and GCP guidelines
• Emphasize strong documentation practices and cross-functional collaboration skills