Medical Writer II (MLR Reviewer)

Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Basic Statistics Interpretation, Clinical Research Knowledge, Evidence Synthesis, Literature Review, Medical Writing, MS Word, Narrative Writing, Scientific Writing Senior Associate Clinical Safety & Pharmacovigilance (ICSR Submission) Department: Pharmacovigilance / Drug Safety Location: Noida Employment Type: Full-Time Experience Required: 35 Years Job Summary The Senior Associate Clinical Safety & Pharmacovigilance is responsible for preparation, quality review, and timely submission of Individual Case Safety Reports (ICSRs) to regulatory authorities, partners, and clients. The role ensures compliance with global pharmacovigilance regulations and supports patient safety through accurate and timely safety reporting. Key Responsibilities Prepare and submit expedited and non-expedited ICSRs to global health authorities and partners. Ensure compliance with FDA, EMA, MHRA, PMDA, Health Canada, and other regulatory requirements. Perform quality checks on case narratives, MedDRA coding, case data, and submission documentation. Generate and transmit E2B(R2/R3) electronic reports through safety databases. Monitor regulatory reporting timelines for serious, unexpected, and reportable adverse events. Track acknowledgment receipts, submission status, and reconciliation activities. Coordinate with case processing, medical review, QA, and regulatory teams. Maintain submission records, audit trails, and inspection documentation. Support SOP improvements and process enhancement initiatives. Required Qualifications Bachelors/Masters degree in Pharmacy. 45 years of experience in Pharmacovigilance or Drug Safety. Strong knowledge of ICSR lifecycle and regulatory reporting. Experience with Oracle Argus Safety, ArisGlobal LifeSphere, or similar systems. Required Skills Knowledge of MedDRA and WHO Drug coding. Understanding of E2B(R2/R3) standards. Strong attention to detail and compliance mindset. Excellent communication and documentation skills. Advanced MS Excel and Word skills. Preferred Experience Gateway submission experience. Knowledge of ICH E2A, E2B, E2D, GVP modules. Experience with PV reconciliation and compliance metrics. Estimated Salary Package (India) 8 14 LPA (Depending on Argus expertise, submission experience, and organization) Senior Associate Clinical Safety & Pharmacovigilance (ICSR Submission) Department: Pharmacovigilance / Drug Safety Location: Noida Employment Type: Full-Time Experience Required: 35 Years Job Summary The Senior Associate Clinical Safety & Pharmacovigilance is responsible for preparation, quality review, and timely submission of Individual Case Safety Reports (ICSRs) to regulatory authorities, partners, and clients. The role ensures compliance with global pharmacovigilance regulations and supports patient safety through accurate and timely safety reporting. Key Responsibilities Prepare and submit expedited and non-expedited ICSRs to global health authorities and partners. Ensure compliance with FDA, EMA, MHRA, PMDA, Health Canada, and other regulatory requirements. Perform quality checks on case narratives, MedDRA coding, case data, and submission documentation. Generate and transmit E2B(R2/R3) electronic reports through safety databases. Monitor regulatory reporting timelines for serious, unexpected, and reportable adverse events. Track acknowledgment receipts, submission status, and reconciliation activities. Coordinate with case processing, medical review, QA, and regulatory teams. Maintain submission records, audit trails, and inspection documentation. Support SOP improvements and process enhancement initiatives. Required Qualifications Bachelors/Masters degree in Pharmacy. 45 years of experience in Pharmacovigilance or Drug Safety. Strong knowledge of ICSR lifecycle and regulatory reporting. Experience with Oracle Argus Safety, ArisGlobal LifeSphere, or similar systems. Required Skills Knowledge of MedDRA and WHO Drug coding. Understanding of E2B(R2/R3) standards. Strong attention to detail and compliance mindset. Excellent communic .