Pharmacovigilance Associate – Safety Data Management
Company: Alvotech
Location: Bangalore Office / India Home Office (Partially Remote)
Job Type: Full-Time
Work Mode: Hybrid / Partially Remote
Application Deadline: March 23, 2026
Job Requisition ID: JR100089
Experience Required
Minimum 2+ years of experience in Pharmacovigilance or Drug Safety, specifically in Safety Data Management functions within the pharmaceutical, biotechnology, or clinical research industry. Candidates should have hands-on experience supporting clinical trial safety and post-marketing pharmacovigilance activities.
Education
Master’s degree in Pharmaceutical Sciences, Pharmacy, Medicine, Life Sciences, or a related healthcare discipline.
Job Overview
Alvotech is seeking a Pharmacovigilance Associate – Safety Data Management to support clinical safety operations and post-marketing pharmacovigilance activities within the Global Safety Data Management team. The role focuses on managing safety data from clinical trials and marketed products, ensuring regulatory compliance, and supporting pharmacovigilance system development and process optimization.
The position operates within the integrated Clinical and Medical Research (iCMR) function and plays a key role in maintaining efficient safety data processes aligned with global regulatory standards.
Key Responsibilities
Perform assigned pharmacovigilance activities related to clinical safety and post-marketing surveillance.
Manage Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) case processing activities.
Support regulatory submissions related to safety reporting and pharmacovigilance compliance.
Conduct literature monitoring and digital platform monitoring for potential safety signals.
Participate in safety database reconciliations and electronic reporting processes including EudraVigilance (EV) and XEVMPD activities.
Support configuration, validation, and lifecycle management of pharmacovigilance safety systems.
Assist in the development and optimization of global pharmacovigilance processes to ensure compliance with international regulations and company procedures.
Collaborate cross-functionally with pharmacovigilance teams such as Benefit-Risk Management, Clinical Operations, and Partner Compliance to ensure timely delivery of safety activities.
Coordinate with internal departments including Regulatory Affairs, Quality Assurance, IT, and Clinical Product Development.
Work with external pharmacovigilance vendors, service providers, and business partners to maintain compliance and operational efficiency.
Deliver training sessions on pharmacovigilance procedures and safety data management standards to internal teams and external stakeholders.
Support internal and external pharmacovigilance audits and regulatory inspections related to safety data management.
Technical Skills and Knowledge
Hands-on experience with pharmacovigilance safety databases such as Argus Safety or ARISg.
Experience with Veeva Safety Vault is considered an advantage.
Understanding of global pharmacovigilance regulations and guidelines including 21 CFR, ICH guidelines, GVP, GCP, and CIOMS standards.
Experience managing global clinical trials and safety data for pharmaceutical or biologic products.
Preferred Experience
Experience working with biologic products or combination products is considered advantageous.
Exposure to safety data management within global clinical development programs.
Professional Skills
Strong organizational and time-management skills with the ability to manage multiple safety tasks simultaneously.
Excellent communication and interpersonal skills to collaborate effectively across cross-functional and multicultural teams.
Ability to work independently while maintaining a high level of accuracy and regulatory compliance.
Strong analytical thinking and attention to detail in safety data evaluation and documentation.
Travel Requirement
Willingness to travel internationally when required for pharmacovigilance activities, audits, or project collaboration.
About Alvotech
Alvotech is a fully integrated specialty biopharmaceutical company focused on the development and manufacturing of high-quality biosimilar medicines. The organization is dedicated to advancing global access to affordable biologic therapies through innovation, scientific expertise, and strong regulatory compliance across international markets.
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