Senior Associate – Clinical Safety & Pharmacovigilance (ICSR Submission) Jobs in Noida | B.Pharm & M.Pharm Apply 2026
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(Senior Associate – Clinical Safety & Pharmacovigilance) |
Introduction
The global pharmacovigilance industry continues to expand as pharmaceutical companies strengthen their commitment to patient safety, regulatory compliance, and post-marketing surveillance. To support increasing safety reporting requirements, a leading pharmaceutical organization is hiring a Senior Associate – Clinical Safety & Pharmacovigilance (ICSR Submission) for its Noida office.
This opportunity is ideal for experienced Pharmacy professionals who have hands-on expertise in Individual Case Safety Report (ICSR) submissions, E2B(R3) reporting, Oracle Argus Safety, and global health authority compliance. Professionals seeking long-term growth in Clinical Safety, Drug Safety Operations, Regulatory Reporting, and Global Pharmacovigilance can benefit significantly from this role.
The position offers exposure to international regulatory agencies, advanced safety reporting systems, and global pharmacovigilance operations, making it a valuable career opportunity for experienced PV professionals.
About the Hiring Organization
The hiring organization is a pharmaceutical and life sciences company engaged in global pharmacovigilance, clinical safety, regulatory affairs, and healthcare compliance. The organization supports pharmaceutical products throughout their lifecycle by ensuring regulatory compliance, safety monitoring, and patient risk management.
Its pharmacovigilance division works closely with international regulatory authorities and utilizes advanced safety systems to manage adverse event reporting, case processing, safety submissions, and compliance monitoring.
Industry Overview
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Industry: Pharmaceutical & Life Sciences
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Department: Clinical Safety & Pharmacovigilance
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Functional Area: Drug Safety Operations
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Location: Noida, India
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Business Focus: Pharmacovigilance, Drug Safety, Regulatory Compliance
Note: Official company details such as headquarters, employee count, and founding year have not been publicly disclosed in the job posting.
Job Overview Summary
The Senior Associate – Clinical Safety & Pharmacovigilance role focuses on global ICSR submission activities and regulatory safety reporting. The selected candidate will be responsible for preparing, reviewing, validating, and submitting safety reports to international health authorities while ensuring compliance with pharmacovigilance regulations.
This position requires strong expertise in global reporting requirements, MedDRA coding, E2B submissions, Oracle Argus Safety, and regulatory timelines. The role also involves collaboration with medical reviewers, case processing teams, regulatory affairs professionals, and quality assurance functions.
Professionals in this role contribute directly to patient safety and regulatory compliance by ensuring timely, accurate safety reporting.
Vacancy Details
Position Information
| Particular | Details |
|---|
| Position | Senior Associate – Clinical Safety & Pharmacovigilance |
| Department | Pharmacovigilance / Drug Safety |
| Job Type | Full-Time |
| Experience | 3–5 Years |
| Qualification | B.Pharm / M.Pharm |
| Location | Noida, India |
Job Role Explanation
What Does a Senior Associate – Clinical Safety & Pharmacovigilance Do?
A Clinical Safety and Pharmacovigilance professional manages the submission of safety reports to regulatory agencies worldwide. The role involves reviewing adverse event cases, validating safety data, preparing electronic reports, and ensuring all submissions comply with global pharmacovigilance requirements.
The position serves as a critical link between case processing teams, medical reviewers, quality functions, and health authorities. Through accurate and timely reporting, Clinical Safety Associates help maintain regulatory compliance while supporting patient safety initiatives across global pharmaceutical programs.
This role is especially suitable for professionals seeking specialization in regulatory safety submissions and global pharmacovigilance operations.
Key Responsibilities
The selected candidate may be responsible for:
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Preparing expedited and non-expedited ICSR submissions
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Submitting safety reports to global health authorities
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Reviewing case data for accuracy and completeness
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Performing quality checks on narratives and coding
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Managing E2B(R2) and E2B(R3) report generation
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Monitoring regulatory submission timelines
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Tracking acknowledgments and submission status
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Performing reconciliation activities
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Maintaining regulatory documentation and audit trails
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Collaborating with case processing and medical review teams
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Supporting inspections and pharmacovigilance audits
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Contributing to SOP updates and process improvements
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Ensuring compliance with international drug safety regulations
Eligibility Criteria
Educational Qualification
Candidates possessing the following qualifications may apply:
Pharmacy Qualifications
Experience Requirement
Applicants should possess:
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3–5 Years of Pharmacovigilance Experience
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Drug Safety Operations Experience
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Hands-on ICSR Submission Experience
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Regulatory Reporting Experience
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Pharmacovigilance Compliance Knowledge
Skills Required
Core Pharmacovigilance Skills
Candidates should have expertise in:
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ICSR Lifecycle Management
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Clinical Safety Reporting
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Pharmacovigilance Compliance
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Adverse Event Reporting
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Case Reconciliation Activities
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Submission Documentation Review
Technical Skills
Knowledge of:
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Oracle Argus Safety
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ArisGlobal LifeSphere
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E2B(R2) Reporting
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E2B(R3) Reporting
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MedDRA Coding
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WHO Drug Coding Concepts
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Microsoft Excel
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Microsoft Word
Regulatory Knowledge
Strong understanding of:
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ICH E2A Guidelines
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ICH E2B Guidelines
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ICH E2D Guidelines
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FDA Safety Reporting
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EMA Reporting Requirements
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MHRA Requirements
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PMDA Reporting Standards
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GVP Modules
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Global Pharmacovigilance Regulations
Professional Skills
Successful candidates generally demonstrate:
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Attention to Detail
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Analytical Thinking
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Regulatory Compliance Awareness
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Documentation Skills
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Communication Skills
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Problem-Solving Ability
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Time Management
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Quality-Oriented Mindset
Preferred Skills
Additional preference may be given to candidates with:
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Gateway Submission Experience
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Health Authority Portal Experience
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Submission Troubleshooting Skills
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PV Compliance Metrics Knowledge
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Audit Readiness Experience
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Regulatory Inspection Support Experience
Salary Estimate
The official salary package has not been disclosed by the employer.
Based on similar Clinical Safety and Pharmacovigilance opportunities in India, the expected compensation range may be:
Estimated Salary Range
Actual compensation may depend on:
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Relevant Experience
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Safety Submission Expertise
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Technical Skills
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Interview Performance
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Internal Compensation Structure
Why Join This Opportunity?
Working in a Clinical Safety & Pharmacovigilance role offers several long-term career benefits.
Key Advantages
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Exposure to Global Regulatory Authorities
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Hands-on E2B(R3) Reporting Experience
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Advanced Oracle Argus Safety Exposure
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International Pharmacovigilance Operations
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Career Growth in Drug Safety
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Global Regulatory Compliance Experience
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Strong Learning Opportunities
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Collaborative Team Environment
The position can serve as a pathway toward senior pharmacovigilance, safety leadership, and regulatory affairs roles.
Interview Details
The official interview process has not been publicly announced. However, candidates may expect:
Step 1: Resume Screening
Evaluation of qualifications and pharmacovigilance experience.
Step 2: Technical Assessment
Topics may include:
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ICSR Processing
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E2B(R2)/(R3) Reporting
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MedDRA Coding
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Regulatory Guidelines
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Oracle Argus Safety
Step 3: Technical Interview
Discussion regarding:
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Safety Submission Experience
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Health Authority Reporting
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Regulatory Compliance
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Case Processing Knowledge
Step 4: HR Discussion
Compensation expectations, notice period, and joining availability.
Step 5: Final Selection
Offer release to successful candidates.
Required Documents
Candidates should keep the following documents ready:
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Updated Resume/CV
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Educational Certificates
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Pharmacy Degree Certificates
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Experience Certificates
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Latest Salary Slip
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Relieving Letter (if applicable)
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Government ID Proof
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Passport-size Photograph
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Pharmacovigilance Training Certificates
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Employment Verification Documents
How to Apply
Interested and eligible candidates can apply through the official application portal.
Application Process:
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Open the application link.
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Complete the online registration form.
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Upload your updated resume.
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Verify all details carefully.
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Submit the application successfully.
Candidates are advised to apply as early as possible to improve their chances of consideration.
Frequently Asked Questions (FAQs)
What position is being offered?
The opportunity is for Senior Associate – Clinical Safety & Pharmacovigilance (ICSR Submission).
What qualifications are eligible?
Candidates with B.Pharm or M.Pharm qualifications can apply.
How much experience is required?
Applicants should have 3–5 years of Pharmacovigilance or Drug Safety experience.
Which pharmacovigilance systems are preferred?
Experience with Oracle Argus Safety, ArisGlobal LifeSphere, and similar PV platforms is preferred.
Is E2B(R3) experience important?
Yes. Hands-on experience with E2B(R2) and E2B(R3) reporting is highly valuable for this position.
Final Conclusion
The Senior Associate – Clinical Safety & Pharmacovigilance opportunity in Noida offers an excellent platform for experienced drug safety professionals looking to strengthen their expertise in global safety reporting and regulatory compliance. The role provides direct exposure to international health authorities, advanced safety databases, and global pharmacovigilance operations.
Professionals with strong ICSR submission experience, Oracle Argus Safety expertise, and knowledge of international pharmacovigilance regulations should strongly consider applying for this opportunity. As pharmaceutical companies continue to expand global safety operations, skilled Clinical Safety professionals remain among the most sought-after talent in the life sciences industry.
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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