Drug Safety Associate – ICSR Processing
Company: Vizen Life Sciences Pvt. Ltd.
Employment Type: Full-Time
Job Function: Pharmacovigilance / Drug Safety
Experience Level: Mid-Level
Experience Required: 2–5 Years
Industry: Pharmaceuticals / Drug Safety / Clinical Research
Job Overview
Vizen Life Sciences Pvt. Ltd. is seeking a Drug Safety Associate (ICSR) with hands-on experience in individual case safety report (ICSR) processing. The role involves end-to-end case management, literature review, safety database entry, and compliance with global pharmacovigilance regulations.
This position is ideal for pharmacovigilance professionals looking to strengthen their expertise in case processing, audit readiness, and regulatory compliance within a growing pharmaceutical organization.
Key Responsibilities
Triage incoming adverse event reports for validity, completeness, and legibility
Perform data entry and case booking into the safety database
Conduct follow-up activities and manage safety queries to resolution
Code adverse events, medical history, concomitant medications, and laboratory data using standard medical dictionaries
Draft high-quality case narratives in accordance with SOPs and regulatory guidelines
Perform literature searches to identify and process safety-relevant cases
Participate in client meetings and support safety-related discussions as required
Support preparation for, participation in, and follow-up activities related to audits and regulatory inspections
Ensure compliance with internal SOPs, global pharmacovigilance regulations, and client requirements
Required Skills & Competencies
Strong analytical and problem-solving skills
Ability to perform safety database and literature searches
Excellent written and verbal communication skills
Strong attention to detail and accuracy
Client-focused and quality-driven approach to work
Ability to work independently as well as in a team environment
Educational Qualification
B.Pharm / M.Pharm / PharmD
Experience Requirements
Minimum 2 years to maximum 5 years of experience in ICSR processing / Drug Safety / Pharmacovigilance
Practical exposure to case triage, data entry, MedDRA coding, narrative writing, and literature case processing
Experience working with safety databases and global PV workflows is preferred
Why Join Vizen Life Sciences?
Opportunity to work on end-to-end ICSR processing
Exposure to audits, inspections, and client-facing activities
Supportive work environment with opportunities for professional growth
Strong focus on quality, compliance, and pharmacovigilance excellence
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