Job Details
- Job Title: Pharmacovigilance Specialist – Safety Data Management
- Job Type: Full-Time
- Work Mode: Partially Remote
- Locations:
- Bangalore Office, India Home Office
- Job Requisition ID: JR100100
- Posted On: Recently Posted
- Application Deadline: March 31, 2026
Pharmacovigilance Specialist jobs
Pharmacovigilance Specialist jobs: A Pharmacovigilance Specialist (PV Specialist) plays a critical role in ensuring the safety of pharmaceutical products throughout their lifecycle. With increasing regulatory scrutiny and global clinical trials, the demand for professionals skilled in safety data management and drug safety monitoring is rapidly growing.
This article explores the role within a leading biopharmaceutical company like Alvotech, focusing on responsibilities, required skills, and career prospects.
About the Company and Department
About Alvotech
Alvotech is a fully integrated specialty biopharmaceutical company dedicated to the development and manufacturing of high-quality biosimilar medicines. The company focuses on improving patient access to affordable biologics worldwide.
Integrated Clinical and Medical Research (iCMR)
Within Research & Development (R&D), the Integrated Clinical and Medical Research (iCMR) department is responsible for:
- Designing clinical strategies aligned with biosimilar guidelines
- Ensuring compliance with global health authorities
- Supporting post-marketing activities
The department is currently undergoing a transformation to modernize and optimize its operational model.
Overview of the Pharmacovigilance Specialist Role
The Pharmacovigilance Specialist – Safety Data Management is responsible for managing:
- Clinical safety data
- Post-marketing pharmacovigilance activities
- Regulatory compliance
This role is part of the Global Safety Data Management Team, working under the Safety Data Management Director.
Key Focus Areas
- Clinical trial safety monitoring
- Post-marketing surveillance
- Safety database management
- Regulatory reporting and compliance
Key Responsibilities of a Pharmacovigilance Specialist
1. Clinical Safety and PV Operations
- Manage ICSR (Individual Case Safety Reports) and SAE (Serious Adverse Events)
- Handle regulatory submissions
- Conduct literature and digital platform monitoring
- Perform reconciliation activities
- Work with databases like EudraVigilance and XEVMPD
2. Safety Data Management Systems
- Configure and validate safety systems such as:
- Argus Safety
- ARISg
- Veeva Vault Safety
- Participate in system lifecycle management
3. Regulatory Compliance and Process Optimization
- Ensure compliance with global regulatory frameworks:
- FDA
- EMA
- ICH
- Develop and optimize pharmacovigilance processes
- Maintain global PV documentation and SOPs
4. Cross-Functional Collaboration
- Work with internal teams:
- Clinical Trials
- Benefit-Risk Management
- Regulatory Affairs
- Quality Assurance
- IT
- Coordinate with external stakeholders:
- PV service providers
- Business partners
5. Training and Knowledge Sharing
- Deliver training on pharmacovigilance processes
- Ensure adherence to global safety standards
6. Audit and Inspection Readiness
- Support internal and external audits
- Ensure inspection readiness for regulatory authorities
Educational Qualifications and Experience
Educational Requirements
- Master’s degree in:
- Pharmaceutical Sciences
- Pharmacy
- Medicine
- Life Sciences
Experience Required
- Minimum 3+ years in Pharmacovigilance or Drug Safety
- Hands-on experience in:
- Clinical trial safety
- Post-marketing surveillance
Essential Skills for PV Specialists
Technical Skills
- Expertise in safety databases:
- Argus Safety
- ARISg
- Veeva Vault (preferred)
- Knowledge of:
- ICSR processing
- Signal detection
- Risk management
Regulatory Knowledge
Strong understanding of:
- 21 CFR regulations
- ICH Guidelines
- GVP (Good Pharmacovigilance Practices)
- GCP (Good Clinical Practice)
- CIOMS guidelines
Soft Skills
- Strong communication skills
- Time management and organization
- Ability to work independently
- Adaptability in multicultural teams
Advantages of Experience in Biologics
Experience with:
- Biologic products
- Combination products
is considered an added advantage, especially in companies like Alvotech that focus on biosimilars.
Career Opportunities in Pharmacovigilance
A role as a Pharmacovigilance Specialist opens pathways to:
- Safety Scientist
- Risk Management Specialist
- PV Operations Lead
- Drug Safety Physician
- Regulatory Affairs roles
Why Choose a Career in Safety Data Management?
- High demand globally
- Opportunity to work on international clinical trials
- Direct impact on patient safety
- Continuous learning in regulatory science
How to apply
Click on it for redirecting to official website so you can apply
Apply Now
Frequently Asked Questions (FAQs)
1. What does a Pharmacovigilance Specialist do?
They monitor, assess, and report adverse drug reactions to ensure patient safety and regulatory compliance.
2. What is ICSR in pharmacovigilance?
ICSR stands for Individual Case Safety Report, which documents adverse events related to drug use.
3. Which software is used in pharmacovigilance?
Common tools include Argus Safety, ARISg, and Veeva Vault Safety.
4. Is pharmacovigilance a good career?
Yes, it offers strong growth, global exposure, and opportunities in clinical research and regulatory affairs.
Conclusion
The role of a Pharmacovigilance Specialist in Safety Data Management is vital in today’s pharmaceutical industry. Companies like Alvotech are actively investing in advanced safety systems and global compliance frameworks, making this career path highly promising for professionals in pharmacy and life sciences.