Clinical Safety & Pharmacovigilance Specialist

Why This Role Matters

Pharmacovigilance plays a critical role in ensuring the safety of medicines throughout their lifecycle, from clinical trials to post-marketing surveillance. Drug safety professionals monitor adverse events, analyze safety data, and ensure compliance with global regulatory standards to protect patient health.
The Pharmacovigilance Specialist role at Alvotech provides an excellent opportunity to work in global safety data management within the biopharmaceutical industry. The position supports safety monitoring for clinical trials and post-marketing programs while ensuring adherence to international pharmacovigilance regulations. As part of the Global Safety Data Management team, the specialist will contribute to safety systems, regulatory submissions, and pharmacovigilance process improvements. This role is especially important for biosimilar products, where rigorous safety monitoring and regulatory compliance are essential to ensure patient safety and product reliability.
For professionals with pharmacovigilance experience, this role offers exposure to global safety operations, regulatory frameworks, and advanced safety systems used in modern drug safety management.

Job Description

Alvotech is seeking a 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 work closely with safety leaders to ensure accurate management of safety data for clinical trials and marketed products. The role includes monitoring adverse events, managing safety reports, ensuring regulatory compliance, and supporting pharmacovigilance system operations.
This position also contributes to developing pharmacovigilance processes, supporting audits and inspections, and collaborating with internal and external stakeholders involved in drug safety and regulatory activities.

Key Features of the Role

• Work within global pharmacovigilance and safety data management
• Exposure to clinical trial safety monitoring and post-marketing surveillance
• Involvement in safety system configuration and lifecycle management
• Opportunity to collaborate with global regulatory and clinical teams
• Participate in pharmacovigilance process development and compliance initiatives
• Contribute to safety monitoring for biosimilar pharmaceutical products

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) management
• Support regulatory safety submissions and reporting requirements
• Conduct literature monitoring and digital platform monitoring for safety signals
• Perform pharmacovigilance reconciliations and safety data verification
• Support activities related to EudraVigilance and XEVMPD

Safety Systems & Data Management

• Support configuration, validation, and lifecycle management of pharmacovigilance systems
• Maintain safety databases and ensure accurate safety data management
• Work with safety systems such as Oracle Argus Safety, ARISg Safety System, and Veeva Vault Safety

Pharmacovigilance Process Management

• Develop and maintain global pharmacovigilance procedures and workflows
• Ensure compliance with international regulatory guidelines and internal SOPs
• Monitor safety processes to maintain regulatory compliance across clinical programs

Cross-Functional Collaboration

• Collaborate with pharmacovigilance teams involved in benefit-risk assessment and clinical safety
• Work with internal 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 to internal staff and external stakeholders
• Support safety-related audits and regulatory inspections
• Ensure documentation and processes meet global regulatory requirements

Required Qualifications

Educational Requirements

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

Experience and Skills

• Minimum 3 years of experience in Pharmacovigilance or Drug Safety
• Experience working in safety data management functions
• Hands-on experience in clinical trial safety and post-marketing pharmacovigilance
• Knowledge of safety databases such as Argus, ARISg, or Veeva Vault Safety
• Experience working with global pharmaceutical products and clinical trials
• Familiarity with biologic or combination products is an advantage

Regulatory Knowledge

• Strong understanding of global pharmacovigilance regulations and guidelines including
• ICH Guidelines
• FDA Regulations
• GVP Guidelines
• GCP Guidelines
• CIOMS Guidelines

Professional Skills

• Strong organizational and time-management skills
• Excellent communication and interpersonal abilities
• Ability to work independently and manage multiple safety activities
• Capability to collaborate effectively in multicultural and global teams

Salary Insights

Although the exact salary has not been disclosed, Pharmacovigilance Specialist roles in the global biopharmaceutical industry typically offer competitive compensation based on experience, expertise, and geographic location. Additional benefits may include international exposure, professional development opportunities, and involvement in global clinical programs for biosimilar medicines.

Company Overview

Alvotech is a fully integrated specialty biopharmaceutical company dedicated to the development and manufacturing of high-quality biosimilar medicines.
The company focuses on improving patient access to biologic treatments by developing cost-effective biosimilars while maintaining strict regulatory and quality standards. Within its Research and Development division, the Integrated Clinical and Medical Research department develops strategies aligned with global biosimilar guidelines and regulatory authority requirements. Through innovative clinical programs and strong pharmacovigilance systems, 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 3 years of pharmacovigilance experience.

What type of work will the PV Specialist perform?
The role includes clinical safety monitoring, adverse event management, safety data analysis, regulatory submissions, and pharmacovigilance system management.

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

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

Application Tips

• Highlight your pharmacovigilance experience and safety data management expertise
• Mention experience working with safety databases such as Argus or Veeva Vault Safety
• Include knowledge of global PV regulations such as ICH, GVP, and GCP guidelines
• Demonstrate experience managing ICSRs, SAE reporting, and safety monitoring
• Emphasize your ability to collaborate with global teams and maintain regulatory compliance