Alvotech Hiring: Pharmacovigilance Associate (Safety Data Management)

Alvotech is inviting applications for the position of Pharmacovigilance Associate, Safety Data Management to support both clinical trial safety and post-marketing pharmacovigilance operations from its Bengaluru facility and India home office model.

Key Job Details

Designation: Pharmacovigilance Associate, Safety Data Management
Company: Alvotech
Experience Required: 2+ years of relevant PV / Drug Safety experience
Education: Master’s Degree in Pharmaceutical Sciences, Pharmacy, Medicine, or related Life Sciences
Location: Bengaluru Office / India Home Office
Industry Sector: Biopharmaceuticals / Biotechnology / Clinical Research
Application Deadline: 29 September 2026

Core Responsibilities

Case & Safety Operations: Execute end-to-end clinical safety and post-marketing pharmacovigilance tasks, including ICSR and SAE processing, literature screening, regulatory safety submissions, digital platform monitoring, reconciliations, and regulatory database handling (EV, XEVMPD).
System Lifecycle & Validation: Participate in safety database setup, configuration, validation, and continuous lifecycle maintenance.
Regulatory Compliance: Maintain adherence to international guidelines and health authority frameworks (FDA, EMA, ICH, GVP, GCP, CIOMS, and 21 CFR).
Cross-Functional Collaboration: Partner with global cross-functional teams including Benefit-Risk Management, Clinical Trials, Partner Compliance, Quality, Regulatory, and external service vendors.
Audits & Training: Support regulatory audits and partner inspections related to safety data management workflows, and provide standard operating training across internal and external stakeholders.

Candidate Profile & Qualifications

Education: Master’s degree in Pharmaceutical Sciences (M.Pharm) or allied disciplines.
Experience: Minimum 2 years of proven safety data management experience covering both clinical trial safety and post-marketing surveillance.
Technical Knowledge:
- Hands-on proficiency with safety databases such as Argus or ARISg (prior experience with Veeva Safety Vault is an added advantage).
- Understanding of biosimilars, biologics, and drug-device combination products.
- Thorough grasp of global pharmacovigilance reporting rules and expedited reporting criteria.
Professional Attributes: Strong organizational discipline, excellent written and verbal communication skills, cross-cultural adaptability, and openness to occasional international travel.