Senior Pharmacovigilance Specialist – Safety Data Management
Company: Alvotech
Location: Bangalore Office / India Home Office (Partially Remote)
Job Type: Full-Time
Application Deadline: March 23, 2026
Job Requisition ID: JR100090
Experience Required
Minimum 5+ years of experience in Pharmacovigilance or Drug Safety, specifically within Safety Data Management functions supporting clinical trials and post-marketing pharmacovigilance activities in the pharmaceutical or biotechnology industry.
Education
Master’s degree in Pharmaceutical Sciences, Pharmacy, Medicine, Life Sciences, or a related healthcare discipline.
Job Overview
Alvotech is seeking a Senior Pharmacovigilance Specialist – Safety Data Management to support global clinical safety operations and post-marketing pharmacovigilance programs. The role will be part of the Global Safety Data Management team within the integrated Clinical and Medical Research (iCMR) function.
The position focuses on managing safety data from clinical trials and marketed products, ensuring compliance with global pharmacovigilance regulations, and contributing to the development and optimization of pharmacovigilance systems and processes. The Senior PV Specialist will work independently, manage assigned activities, and collaborate with cross-functional teams to maintain regulatory compliance and operational excellence.
Key Responsibilities
Manage assigned clinical safety and post-marketing pharmacovigilance activities including ICSR and SAE case management.
Support regulatory safety submissions and reporting requirements across global health authorities.
Conduct literature monitoring and digital platform monitoring to identify potential safety signals.
Perform pharmacovigilance data reconciliation activities and electronic reporting processes including EudraVigilance (EV) and XEVMPD submissions.
Participate in pharmacovigilance safety system setup, configuration, validation, and lifecycle management.
Develop, maintain, and optimize global pharmacovigilance processes to ensure compliance with international regulations and internal procedures.
Collaborate with pharmacovigilance teams including Benefit-Risk Management, Clinical Development, and Partner Compliance to ensure timely delivery of safety activities.
Work cross-functionally with departments such as Quality Assurance, Regulatory Affairs, Information Technology, and Clinical Product Development.
Coordinate with external pharmacovigilance vendors, service providers, and business partners to maintain operational efficiency and compliance.
Deliver pharmacovigilance training programs and guidance to internal staff 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 advantageous.
Strong knowledge of global pharmacovigilance regulations and guidelines including 21 CFR, ICH guidelines, GVP, GCP, and CIOMS standards.
Experience managing global safety data from clinical trials and marketed pharmaceutical products.
Preferred Qualifications
Experience working with biologic or combination products is considered advantageous.
Prior experience supporting global pharmacovigilance activities within multinational clinical development programs.
Professional Skills
Strong organizational and time-management skills with the ability to manage multiple safety activities simultaneously.
Excellent communication and interpersonal skills for working in cross-functional and multicultural environments.
Ability to work independently while maintaining high levels of accuracy and regulatory compliance.
Strong analytical thinking and problem-solving capabilities.
Travel Requirement
Willingness to travel internationally when required for project collaboration, audits, or pharmacovigilance-related activities.
About Alvotech
Alvotech is a global biopharmaceutical company dedicated to the development and manufacturing of high-quality biosimilar medicines. The company focuses on improving global access to biologic therapies through advanced research, regulatory excellence, and international clinical development programs.
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