Pharmacovigilance Associate - Safety Data Management

Why This Role Matters

Pharmacovigilance is essential for ensuring the safety and effectiveness of medicines throughout their lifecycle. From clinical trials to post-marketing surveillance, pharmacovigilance professionals monitor adverse events, analyze safety data, and ensure that pharmaceutical products comply with global regulatory requirements. The Pharmacovigilance Associate role at Alvotech plays a key part in supporting global safety data management for biosimilar medicines. The position contributes to the monitoring of safety data generated from clinical trials and post-marketing programs while maintaining compliance with international pharmacovigilance regulations.
Working within the Global Safety Data Management team, the PV Associate will assist in managing adverse event reports, monitoring safety signals, and supporting pharmacovigilance system operations. This role also contributes to improving pharmacovigilance processes and ensuring regulatory compliance across global safety programs. For professionals with pharmacovigilance experience, this role offers valuable exposure to global drug safety operations, safety databases, and regulatory frameworks governing biosimilar medicines.

Job Description

Alvotech is seeking a motivated Pharmacovigilance Associate to support clinical safety and post-marketing pharmacovigilance activities within its Research and Development function. The selected candidate will be part of the Global Safety Data Management team and will contribute to safety data handling, regulatory reporting, and pharmacovigilance process development. The role involves working with safety databases, managing adverse event cases, and ensuring that safety information is processed in accordance with international regulatory requirements.
The PV Associate will collaborate with multiple internal departments and external partners to ensure timely safety reporting and regulatory compliance across global clinical and post-marketing programs.

Key Features of the Role

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

Responsibilities

Clinical Safety & Pharmacovigilance Activities

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

Safety Systems & Data Management

• Assist in 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 Support

• Assist in maintaining and optimizing global pharmacovigilance procedures
• Ensure compliance with internal SOPs and international safety regulations
• Support safety documentation and regulatory compliance activities

Cross-Functional Collaboration

• Work 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

• Support pharmacovigilance training for internal staff and external stakeholders
• Assist in safety-related audits and regulatory inspections
• Maintain accurate documentation to meet global regulatory requirements

Required Qualifications

Educational Requirements

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

Experience and Skills

• Minimum 2 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
• Familiarity with pharmacovigilance safety databases
• Experience working with global pharmaceutical products and clinical trials
• Knowledge of biologic or combination products is considered an advantage

Regulatory Knowledge

• 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 organizational and time-management skills
• Excellent written and verbal communication abilities
• Ability to manage multiple safety activities and meet deadlines
• Capability to work independently and collaboratively in multicultural teams

Salary Insights

Although the exact salary has not been specified, Pharmacovigilance Associate roles in the global biopharmaceutical industry typically offer competitive compensation based on experience, location, and expertise. Employees may also receive additional benefits such as professional development opportunities, global project exposure, and involvement in innovative biosimilar research programs.

Company Overview

Alvotech is a global biopharmaceutical company focused on developing and manufacturing high-quality biosimilar medicines.
The company specializes in improving access to biologic treatments by producing cost-effective biosimilars while maintaining strict regulatory, safety, 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 to support successful clinical studies and post-marketing safety programs.
Through advanced pharmacovigilance systems and global safety monitoring processes, Alvotech ensures that its biosimilar medicines meet international safety and regulatory standards.

FAQs

Who can apply for this role?
Candidates with a Master’s degree in Pharmacy, Life Sciences, or Medicine and at least 2 years of pharmacovigilance experience.

What type of work does the PV Associate perform?
The role involves adverse event case processing, safety monitoring, regulatory reporting, safety database 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 experience and safety data management expertise
• Include experience working with ICSR processing and SAE reporting
• Mention 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 attention to detail