Pharmacovigilance Specialist - ICSR Quality Review & Regulatory Submissions

Why This Role Matters
Pharmacovigilance plays a crucial role in safeguarding public health by ensuring the safe use of medicines and monitoring potential risks associated with pharmaceutical products. The role of a Pharmacovigilance Specialist focusing on ICSR Quality Review and Regulatory Submissions is vital in maintaining compliance with global safety regulations and ensuring that adverse event reports are accurately reviewed, processed, and submitted to health authorities within regulatory timelines.
This position ensures that pharmaceutical companies meet their legal obligations for safety reporting while maintaining the highest standards of data quality and regulatory compliance. By reviewing Individual Case Safety Reports (ICSRs), approving submissions, and coordinating with internal safety teams, the specialist helps protect patient safety and supports the continuous monitoring of product safety profiles.

Job Description
The Pharmacovigilance Specialist – ICSR Quality Review & Regulatory Submissions is responsible for reviewing safety cases, ensuring accuracy and completeness of pharmacovigilance data, and approving regulatory submissions to health authorities. The role requires expertise in pharmacovigilance regulations, strong attention to detail, and hands-on experience with safety databases such as Argus.
Working within a pharmacovigilance team, the professional ensures that safety cases meet global regulatory requirements before submission to health authorities, business partners, or affiliates. The role also involves coordinating regulatory timelines, ensuring compliance with pharmacovigilance guidelines, and supporting overall drug safety operations within the organization.

Key Features of the Role:
The role offers exposure to global pharmacovigilance regulatory frameworks and real-world safety data management. Professionals working in this position gain experience in regulatory submissions, quality review of safety cases, and health authority reporting obligations.
The position also provides opportunities to collaborate with cross-functional teams including drug safety associates, regulatory affairs professionals, and quality assurance teams. This environment supports professional development in pharmacovigilance compliance, safety reporting systems, and global regulatory practices.

Responsibilities
Approve and schedule safety reports in the Argus safety database for submission to relevant Health Authorities as per regulatory requirements.
Review Individual Case Safety Reports (ICSRs) for quality, accuracy, and completeness before regulatory submission.
Submit validated safety cases to Health Authorities, business partners, and affiliate organizations within required timelines.
Ensure strict adherence to internal and external reporting timelines to maintain regulatory compliance.
Schedule and approve regulatory reports according to country-specific reporting obligations and global pharmacovigilance guidelines.
Perform quality checks to ensure data integrity, accurate coding, and compliance with pharmacovigilance standards.
Collaborate with pharmacovigilance teams to resolve discrepancies and ensure proper documentation of safety reports.
Support regulatory inspections, internal audits, and quality reviews related to pharmacovigilance processes.

Required Qualifications

Educational Requirements:
Candidates should possess one of the following qualifications:
B.Pharm (Bachelor of Pharmacy)
M.Pharm (Master of Pharmacy)

Experience and Skills:
Candidates should have 4–6 years of relevant experience in Pharmacovigilance, particularly in ICSR Quality Review and Regulatory Submissions.
Hands-on experience working with the Argus Safety Database is mandatory.
Strong understanding of global pharmacovigilance regulations and health authority submission requirements.
Experience in safety data review, regulatory reporting timelines, and pharmacovigilance compliance processes.
Excellent analytical skills and attention to detail to ensure accuracy in safety case review.
Strong communication skills to coordinate with internal teams and regulatory stakeholders.
Ability to manage multiple priorities and meet strict regulatory deadlines.

Salary Insights
The salary for a Pharmacovigilance Specialist – ICSR Quality Review & Regulatory Submissions varies depending on experience, organization, and location.
For professionals with 4–6 years of pharmacovigilance experience in India, the average annual salary typically ranges between ₹6 LPA and ₹12 LPA. Compensation may also include performance incentives, professional training opportunities, and career advancement within the drug safety domain.

Company Overview
Vizen Life Sciences Pvt. Ltd. is a pharmaceutical and life sciences organization focused on delivering high-quality services in pharmacovigilance, clinical research, and regulatory support. The company provides drug safety solutions to pharmaceutical companies by ensuring compliance with global pharmacovigilance standards and regulatory requirements.
The organization emphasizes patient safety, regulatory excellence, and continuous improvement in drug safety monitoring systems. By integrating advanced safety databases and expert professionals, the company supports pharmaceutical partners in maintaining safe and effective medicines in the global healthcare market.

FAQs

1. What does an ICSR Quality Review Specialist do?
An ICSR Quality Review Specialist checks Individual Case Safety Reports for accuracy, completeness, and compliance before submission to health authorities.

2. What is the Argus Safety Database?
Argus is a widely used pharmacovigilance database that helps manage adverse event reports, case processing, and regulatory submissions for pharmaceutical companies.

3. Is pharmacovigilance experience mandatory for this role?
Yes, candidates should have relevant pharmacovigilance experience, particularly in case processing, quality review, or regulatory submissions.

4. What career growth opportunities exist in this field?
Professionals can progress to roles such as Senior Pharmacovigilance Specialist, Drug Safety Manager, or Global Safety Lead.

Application Tips
Highlight your experience with pharmacovigilance databases such as Argus or similar safety systems.
Emphasize your expertise in ICSR case review, regulatory reporting timelines, and global pharmacovigilance guidelines.
Mention your ability to manage safety submissions under strict regulatory deadlines.
Include any experience with regulatory audits, quality checks, or health authority interactions, as these are highly valued skills in pharmacovigilance roles.
Tailoring your resume to showcase pharmacovigilance compliance knowledge and hands-on database experience will significantly increase your chances of securing this position.