ICSR Submissions Specialist (Pharmacovigilance)

Ocugen India Pvt Ltd; Hyderabad; On-site; INR 1,200,000 - 2,400,000; Full time

Benefits offered by this job

OPD health insurance

Performance incentives

Job summary

Ocugen India Pvt Ltd is seeking an ICSR Submissions Specialist (Pharmacovigilance) to ensure accurate, compliant, and timely submission of ICSRs to global regulatory authorities. You will manage end-to-end case submissions, support cross-functional teams, and maintain inspection-ready documentation.

The role requires expertise in ICH E2B (R2/R3), 3+ years of hands-on ICSR submission experience, and proficiency in Argus Safety.

Qualifications

• Bachelor's or Master's degree in pharmacy, life sciences, or medicine.
• 5 years of experience in Pharmacovigilance.
• Minimum 3 years of hands-on experience in ICSR submissions.
• Strong knowledge of ICH E2B (R2/R3), global ICSR timelines, and regional regulatory requirements.
• Proficient in Argus Safety (mandatory), E2B gateways, and regulatory portals.
• Expert in supporting global submissions across EU, US, and Rest of World.
• Proven background in CRO & pharmaceutical environments.

Responsibilities

• Manage end-to-end ICSR submissions to global regulatory authorities in compliance with timelines.
• Ensure timely submission of expedited and nonexpedited cases, including follow-ups.
• Perform E2B(R2/R3) electronic submissions via regulatory gateways.
• Monitor submission status, acknowledgements, and agency responses; resolve failures or rejections.
• Support regulatory inspections, audits, and health authority queries with submission evidence.

Skills

ICSR submissions

Regulatory knowledge

Quality assurance

Communication

Education

Bachelor's or Master's in Pharmacy / Life Sciences / Medicine

Tools

Argus Safety

E2B gateways

Regulatory portals

Job description

Job title- ICSR Submissions Specialist (Pharmacovigilance)Reports to-VP Operations

Job purpose

The ICSR Submission Specialist (Pharmacovigilance) will be responsible to ensure the accurate, compliant, and timely submission of Individual Case Safety Reports (ICSRs) to global regulatory authorities by managing end-to-end case submission activities. The role safeguards regulatory compliance and uninterrupted pharmacovigilance reporting operations through effective handling of expedited and periodic safety reports, resolution of technical transmission issues, and maintenance of inspection-ready documentation. By collaborating cross-functionally with Case Processing, QA, IT, and Regulatory teams, the specialist supports global drug safety obligations and contributes to the integrity of patient safety data.

Duties and responsibilities

• Manage endtoend ICSR submissions to global regulatory authorities (e.g., FDA, EMA, MHRA, PMDA, Health Canada) in compliance with regional and global reporting requirements.
• Ensure timely submission of expedited (7day, 15day) and nonexpedited cases, including followups, in accordance with regulatory timelines and internal SOPs.
• Perform E2B(R2/R3) electronic submissions via regulatory gateways, ensuring successful transmission, acknowledgements, and resolution of technical errors.
• Monitor and track submission status, acknowledgements, and agency responses; proactively investigate and resolve submission failures or rejections.
• Conduct quality and compliance checks on ICsrs prior to submission to ensure data completeness, accuracy, and regulatory acceptability.
• Collaborate closely with Case Processing, QA, IT, and Regulatory Affairs teams to support uninterrupted submission operations and address data or system issues.
• Maintain submission logs, reconciliation records, and compliance metrics to support inspections, audits, and management reporting.
• Serve as a subjectmatter expert (SME) for ICSR submission processes, regulatory requirements, and system functionalities.
• Support regulatory inspections, audits, and health authority queries, providing submission evidence and compliance documentation as required.
• Ensure adherence to global safety reporting standards, including ICH E2B, ICH E2A, and applicable GVP/21 CFR requirements.
• Identify opportunities for process improvement and automation, contributing to increased efficiency and reduced submission errors.
• Provide training and guidance to junior team members on submission procedures, regulatory expectations, and system usage.

Qualifications

• Bachelors or masters degree in pharmacy, Life Sciences, or Medicine
• 5 years of experience in Pharmacovigilance
• Minimum 3 years of handson experience in ICSR submissions
• Strong knowledge of ICH E2B (R2/R3), global ICSR reporting timelines, and regional regulatory requirements
• Proficient in Argus Safety (mandatory), E2B gateways, and regulatory portals
• Expert in supporting global submissions across EU, US, and Rest of World
• Proficient in partner safety data exchange agreements
• Mandatory exposure to signal management & aggregate reporting
• Proven background in CRO & pharmaceutical environments

Working conditions

This position is fully officebased (onsite).Job may require availability beyond standard working hours to support priority business needs, audits, or inspections.

Physical requirements

This is a largely sedentary role.Direct Reports N/A .