Pharmacovigilance Services Senior Analyst
Location: Bengaluru, India
Employment Type: Full-time
Experience Required: 5–8 Years
Job ID: AIOC-S01615678
Industry: Life Sciences | Pharmacovigilance | Drug Safety
Job Overview
We are seeking a highly motivated Pharmacovigilance Services Senior Analyst to join a global Life Sciences and R&D services organization. This role is critical in supporting end-to-end drug safety and pharmacovigilance operations for leading biopharmaceutical clients worldwide. The ideal candidate will bring strong expertise in Individual Case Safety Report (ICSR) processing, global regulatory compliance, and safety surveillance.
This position offers an opportunity to work in a dynamic, fast-paced environment aligned with global pharmacovigilance standards and patient safety objectives.
Key Responsibilities
Manage affiliate safety mailboxes and perform reconciliation of safety reports as per defined processes
Conduct written follow-ups for both serious and non-serious adverse event cases
Perform end-to-end ICSR lifecycle activities, including:
Case identification and intake
Data entry and narrative writing
MedDRA coding
Case processing and quality review
Submission to health authorities and business partners
Timely follow-ups and case closure
Ensure compliance with global pharmacovigilance regulations (ICH, FDA, EMA, MHRA, etc.) and client-specific guidelines
Support safety database activities and maintain accurate documentation
Collaborate with internal teams and stakeholders to ensure high-quality pharmacovigilance deliverables
Contribute to continuous process improvement initiatives within drug safety operations
Required Qualifications
Education: Bachelor of Pharmacy (B.Pharm)
Experience:
Minimum 5 to 8 years of hands-on experience in pharmacovigilance and drug safety operations
Proven experience in ICSR processing for global markets
Strong working knowledge of:
Pharmacovigilance regulations and guidelines
MedDRA coding standards
Safety databases and case processing workflows
Skills & Competencies
Ability to analyze and resolve complex safety-related problems
Strong attention to detail and quality orientation
Ability to work independently with minimal supervision
Effective communication and stakeholder interaction skills
Adaptability to changing priorities and regulatory requirements
Willingness to work in rotational shifts, if required
Career Environment
You will be part of a global Life Sciences R&D vertical supporting clinical research, regulatory services, pharmacovigilance, and patient safety solutions. The role provides exposure to international clients and complex drug safety programs, enabling strong career growth in global pharmacovigilance operations.
Equal Opportunity Statement
The organization is committed to equal employment opportunity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by applicable law. Employment decisions are based solely on merit, qualifications, and business needs.
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