Alvotech, a globally recognized biosimilar pharmaceutical company, is hiring for Pharmacovigilance Associate, Pharmacovigilance Specialist, and Senior Pharmacovigilance Specialist positions in Bangalore, India. These roles are part of the Global Safety Data Management team and focus on clinical trial safety monitoring, post-marketing pharmacovigilance activities, and regulatory compliance.
This opportunity is ideal for professionals with experience in drug safety, pharmacovigilance systems, ICSR management, and global regulatory requirements such as ICH, GVP, and FDA guidelines.
Candidates with experience in Argus Safety, ARISg, or Veeva Safety Vault and a background in clinical safety data management are strongly encouraged to apply.
Job Overview
| Position | Experience | Location | Work Model |
|---|---|---|---|
| Pharmacovigilance Associate | 2+ Years | Bangalore | Partially Remote |
| Pharmacovigilance Specialist | 3+ Years | Bangalore | Partially Remote |
| Senior Pharmacovigilance Specialist | 5+ Years | Bangalore | Partially Remote |
Company: Alvotech
Department: Clinical & Medical Research (iCMR)
Function: Safety Data Management / Pharmacovigilance
Key Responsibilities
Professionals joining the Alvotech Pharmacovigilance team will work on global safety monitoring and compliance activities.
Primary responsibilities include:
- Managing Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs)
- Handling regulatory submissions for drug safety reports
- Performing literature surveillance and digital safety monitoring
- Conducting safety database reconciliation and compliance checks
- Supporting EudraVigilance (EV) and XEVMPD submissions
- Managing pharmacovigilance systems lifecycle including configuration and validation
- Ensuring compliance with international PV regulations (FDA, EMA, ICH, GVP, GCP)
- Collaborating with clinical, regulatory, quality, and IT teams
- Supporting PV audits and regulatory inspections
- Delivering pharmacovigilance training programs to internal and external stakeholders
These roles are critical in ensuring patient safety, drug risk monitoring, and regulatory compliance across global clinical trials and post-marketing surveillance programs.
Eligibility & Qualifications
Candidates applying for Pharmacovigilance jobs at Alvotech should meet the following criteria:
Education
- Masterโs degree in:
- Pharmacy
- Pharmaceutical Sciences
- Medicine
- Life Sciences
Experience Requirements
| Role | Experience |
|---|---|
| PV Associate | 2+ years in Pharmacovigilance |
| PV Specialist | 3+ years in Drug Safety |
| Senior PV Specialist | 5+ years in Safety Data Management |
Required Skills
- Experience in pharmacovigilance and drug safety operations
- Knowledge of ICSR processing and SAE management
- Understanding of global PV regulations (ICH, GVP, FDA, CIOMS, 21 CFR)
- Hands-on experience with safety databases like Argus or ARISg
- Exposure to Veeva Safety Vault (preferred)
- Experience working on clinical trial safety and post-marketing PV
- Strong communication, compliance, and documentation skills
Experience with biologics or biosimilar products will be an added advantage.
Benefits of Working at Alvotech
Joining Alvotech offers several career advantages for pharmacovigilance professionals:
- Opportunity to work with a global biosimilar pharmaceutical company
- Exposure to international clinical trials and safety reporting systems
- Work with advanced pharmacovigilance technologies and safety databases
- Career growth in drug safety, regulatory compliance, and clinical research
- Collaboration with global teams across clinical, regulatory, and quality functions
- Hybrid working model with partially remote flexibility
Why This Pharmacovigilance Job is Important
Pharmacovigilance professionals play a crucial role in monitoring drug safety and protecting patient health. In biosimilar development, robust safety data management and risk monitoring systems are essential to ensure regulatory approvals and post-marketing surveillance.
Working in Safety Data Management at Alvotech allows professionals to gain exposure to global drug safety systems, regulatory submissions, and benefit-risk evaluation processes.
How to Apply
Application Link For PV Associate
Application Link For PV Specialist
Application Link For Senior PV Specialist
| Role | Experience | Estimated Salary |
|---|---|---|
| Pharmacovigilance Associate | 2+ years | โน4 LPA โ โน7 LPA |
| Pharmacovigilance Specialist | 3+ years | โน8 LPA โ โน14 LPA |
| Senior Pharmacovigilance Specialist | 5+ years | โน15 LPA โ โน25 LPA |