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Arcolab Hiring XEVMPD/PSMF Associate in Bengaluru | Pharmacovigilance Jobs India 2026
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Arcolab Hiring XEVMPD/PSMF Associate in Bengaluru | Pharmacovigilance Jobs India 2026
(Arcolab Hiring XEVMPD/PSMF Associate in Bengaluru)
Introduction
Professionals looking to grow their career in Pharmacovigilance (PV), Drug Safety, and Regulatory Compliance now have an excellent opportunity with Arcolab in Bengaluru. The company is hiring experienced candidates for the position of XEVMPD/PSMF Associate, focusing on global pharmacovigilance documentation, regulatory database management, and aggregate safety reporting.
This role is ideal for candidates who have hands-on experience in PSMF maintenance, XEVMPD submissions, PSUR/PADER writing, and ICSR management. The opportunity provides exposure to international regulatory frameworks such as EMA and MHRA, making it highly valuable for professionals planning long-term careers in global drug safety operations.
As pharmacovigilance and regulatory affairs continue to expand globally in 2026, experienced PV professionals are becoming increasingly important for pharmaceutical companies handling worldwide compliance and patient safety monitoring.
About The Company
Arcolab is a pharmaceutical and healthcare-focused organization known for its involvement in drug safety operations, regulatory support, and healthcare compliance systems. The company works in areas related to pharmaceutical manufacturing, healthcare research, pharmacovigilance, and regulatory affairs.
Arcolab focuses on maintaining global regulatory standards while supporting pharmaceutical safety systems and compliance-driven healthcare operations. The organization provides professionals with opportunities to work on international pharmacovigilance frameworks and global safety databases.
Company Details
Company Name: Arcolab
Industry: Pharmaceutical & Pharmacovigilance
Headquarters: Bengaluru, Karnataka, India
Founded: 1980s (pharmaceutical business operations expansion period)
Employee Strength: Thousands of employees globally
Work Model: Full-time On-site
The company continues to expand its pharmacovigilance and regulatory operations to support global healthcare compliance systems and international drug safety monitoring requirements.
Job Overview Summary
Arcolab is hiring an experienced XEVMPD/PSMF Associate for its Bengaluru office. The role involves handling pharmacovigilance documentation, aggregate report preparation, medicinal product database submissions, and ICSR data management activities.
Selected candidates will work on maintaining compliance with international pharmacovigilance regulations while coordinating with global safety teams and regulatory stakeholders.
This role is highly suitable for professionals experienced in:
Pharmacovigilance Systems
PSMF Documentation
XEVMPD Filings
Aggregate Safety Reports
EMA & MHRA Compliance
ICSR Data Handling
The position provides excellent exposure to international regulatory systems and advanced drug safety workflows.
Vacancy Details
Job Details
Information
Company Name
Arcolab
Job Role
XEVMPD/PSMF Associate
Job Location
Bengaluru, Karnataka, India
Job Type
Full-time
Industry
Pharmacovigilance / Drug Safety
Experience Required
4 – 8 Years
Qualification
Pharmacy / Life Sciences
Work Mode
On-site
Department
Pharmacovigilance & Regulatory Affairs
Responsibility Explanation
1. PSMF Authoring & Maintenance
The selected candidate will develop, review, and maintain the Pharmacovigilance System Master File (PSMF). This document is critical for regulatory inspections and global pharmacovigilance compliance.
The role also includes coordinating with different departments to collect updated PV system information and ensure regulatory accuracy.
2. XEVMPD Filings
Candidates will manage XEVMPD submissions and maintain medicinal product data in EudraVigilance databases.
This responsibility requires strong attention to detail because product information submitted to regulatory authorities must remain accurate and compliant with EMA standards.
3. Aggregate Report Writing
The role includes preparation and review of:
PSURs (Periodic Safety Update Reports)
PADERs (Periodic Adverse Drug Experience Reports)
Candidates may also support signal detection activities and safety data trend analysis.
This work is highly important in evaluating the benefit-risk profile of pharmaceutical products.
4. ICSR Data Management
Professionals will handle Individual Case Safety Reports (ICSRs) from EMA and MHRA databases.
Responsibilities include:
Downloading safety reports
Reviewing case quality
Ensuring data consistency
Supporting case processing teams
This process helps maintain accurate pharmacovigilance records and patient safety monitoring systems.
Eligibility Criteria
Educational Qualification
Candidates with the following qualifications are eligible to apply:
Bachelor’s Degree in Pharmacy or Life Sciences
Master’s Degree in Pharmacy or Life Sciences
Related Healthcare or Clinical Research Qualification
Experience Required
4 to 8 years of Pharmacovigilance experience
Required Technical Knowledge
Candidates should have expertise in:
PSMF authoring and maintenance
XEVMPD filings
PSUR and PADER writing
ICSR management
EMA guidelines
MHRA compliance systems
Skills Required
Technical Skills
Pharmacovigilance documentation expertise
Regulatory database handling
Aggregate safety reporting
Drug safety data analysis
Regulatory compliance management
Knowledge of EudraVigilance systems
Analytical Skills
The role requires:
Strong analytical thinking
Detail-oriented documentation review
Problem-solving ability
Data quality assessment skills
Communication Skills
Candidates should possess:
Professional communication skills
Cross-functional collaboration ability
Report writing expertise
Regulatory coordination capabilities
Salary Estimate
The estimated salary for this Pharmacovigilance role may range between ₹8 LPA to ₹15 LPA, depending on:
Experience level
Global PV expertise
Regulatory knowledge
Aggregate report writing skills
Database handling experience
Professionals with advanced expertise in EMA, MHRA, PSMF, and XEVMPD systems may receive higher compensation packages in the global pharmacovigilance industry.
Candidates should keep the following documents ready before applying:
Updated Resume/CV
Educational Certificates
Experience Letters
Salary Slips (if required)
Government ID Proof
Pharmacovigilance Certifications
Regulatory Training Certificates
Passport-size Photograph
Frequently Asked Questions (FAQs)
1. What is the job role offered by Arcolab?
Arcolab is hiring for the position of XEVMPD/PSMF Associate in Bengaluru.
2. What experience is required for this pharmacovigilance job?
Candidates with 4–8 years of pharmacovigilance experience are preferred.
3. Which regulatory systems are involved in this role?
The role involves EMA, MHRA, EudraVigilance, and global pharmacovigilance systems.
4. What qualifications are eligible for this role?
Candidates with Pharmacy or Life Sciences backgrounds can apply.
5. What are the important skills required?
PSMF authoring, XEVMPD filings, PSUR/PADER writing, and ICSR handling are key skills.
6. What is the expected salary for this position?
The estimated salary ranges between ₹8 LPA and ₹15 LPA.
7. Is this role suitable for freshers?
No, the company is specifically looking for experienced pharmacovigilance professionals.
8. Where is the job location?
The position is based in Bengaluru, Karnataka, India.
Final Conclusion
Arcolab’s XEVMPD/PSMF Associate opening in Bengaluru is an excellent opportunity for experienced Pharmacovigilance professionals seeking growth in global regulatory compliance and drug safety operations.
The role provides valuable exposure to:
International PV systems
EMA & MHRA compliance
Aggregate safety reporting
Global pharmacovigilance databases
As the pharmaceutical industry continues expanding globally in 2026, experienced professionals with expertise in PSMF, XEVMPD, and ICSR management are becoming highly valuable in regulatory and drug safety domains.
Candidates with strong documentation skills, regulatory understanding, and pharmacovigilance expertise should consider applying early for this opportunity.
Disclaimer
Note: Pharma Duniya does not charge any money for job information. Candidates are advised to verify details from the official company website.
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