Job Description: Submission - Senior Associate
Department: Pharmacovigilance / Drug Safety
Job Summary
The Pharmacovigilance Submission Associate (ICSR) is responsible for the preparation, quality review, and timely electronic/manual submission of Individual Case Safety Reports (ICSRs) to regulatory authorities, partners, and clients in compliance with global pharmacovigilance regulations and company procedures. The role supports patient safety by ensuring accurate and compliant safety reporting within regulatory
timelines.
Key Responsibilities
- Prepare and submit expedited and non-expedited ICSRs to global regulatory authorities and business partners.
- Ensure submissions comply with applicable regulatory requirements, including FDA, EMA, MHRA, PMDA, Health Canada, and other health authorities.
- Perform quality control checks on case data, narratives, MedDRA coding, and submission documentation.
- Generate and transmit E2B(R3) electronic reports through safety databases and reporting gateways.
- Monitor submission timelines and ensure compliance with reporting requirements for serious, unexpected, and reportable adverse events.
- Track acknowledgment receipts, submission statuses, and reconciliation activities.
- Coordinate with case processing, medical review, quality assurance, and regulatory aairs teams to resolve case-related queries.
- Maintain accurate documentation, submission records, and audit trails.
- Support health authority inspections and internal audits by providing required submission documentation.
- Participate in process improvement initiatives and SOP reviews to enhance submission quality and efficiency.
Required Qualifications
- Bachelor's or master's degree in pharmacy.
- 4-5 years of experience in Pharmacovigilance, Drug Safety, or ICSR submission activities.
- Understanding of global pharmacovigilance regulations and reporting requirements.
- Experience with safety databases such as Oracle Argus Safety, Aris Global LifeSphere, or similar PV systems.
Required Skills
- Strong knowledge of ICSR lifecycle and regulatory reporting timelines.
- Familiarity with E2B(R2)/E2B(R3) submission standards.
- Knowledge of MedDRA and WHO Drug coding concepts.
- Excellent attention to detail and data quality focus.
- Strong organizational and time management skills.
- Ability to manage multiple submissions within stringent regulatory deadlines.
- Effective written and verbal communication skills.
- Proficiency in Microsoft Oice applications, particularly Excel and Word
Preferred Skills
- Experience with gateway submissions and health authority portals.
- Knowledge of ICH E2A, E2B, E2D, GVP Modules, and FDA safety reporting requirements.
- Experience in reconciliation activities and submission troubleshooting.
- Understanding of PV compliance metrics and reporting.
