Senior Specialist – ICSR Management (Pharmacovigilance)
Company: GSK (GlaxoSmithKline)
Location: Bengaluru, Karnataka, India
Work Type: Full-Time
Function: Medical and Clinical / Pharmacovigilance
Job ID: 432438
Posted Date: 18 December 2025
Site: Bengaluru Luxor North Tower
Job Overview
GSK, a global biopharmaceutical leader, is seeking a Senior Specialist, ICSR Management to join its Pharmacovigilance Operations team in Bengaluru. This role is critical to ensuring high-quality Individual Case Safety Report (ICSR) management across the lifecycle of clinical trials and marketed products, in compliance with global regulatory standards.
The successful candidate will work within a complex global matrix environment, supporting case processing, vendor oversight, system configuration, and continuous improvement initiatives across global safety operations.
Key Responsibilities
Manage end-to-end ICSR case handling activities, from case intake through expedited reporting, in compliance with internal standards and global regulatory requirements
Collaborate with cross-functional stakeholders including Safety Evaluation and Risk Management (SERM), Local Operating Companies (LOCs), Clinical Operations, and CRO partners to ensure accurate safety data capture and reporting
Identify, investigate, and resolve case management issues; perform root cause analysis and implement corrective and preventive actions (CAPAs)
Escalate quality, compliance, or delivery issues to Pharmacovigilance Operations leadership as required
Contribute to the development and global implementation of process improvements and best practices within PV Operations
Provide oversight of third-party vendors to ensure quality-driven case management processes
Support and mentor technical associates to enhance ICSR management knowledge and performance
Support study and program setup activities, including review of protocols, safety management plans, data management plans, AE/SAE forms, contracts, and regulatory documentation
Assist with safety system activities including Argus configuration, user acceptance testing (UAT), vendor training, and submission setup
Support reconciliation activities, spot checks (e.g., JIRA), and study close-out processes
Monitor and analyze key performance indicators (KPIs) from vendors and quality teams to identify risks and ensure compliance
Manage pharmacovigilance operations mailboxes and provide timely responses to spontaneous and clinical trial safety queries
Maintain expert-level awareness of global pharmacovigilance regulations, CRO and licensing partner reporting rules, and submission timelines
Required Qualifications
Bachelor’s degree in Pharmacy, Life Sciences, Biomedical Sciences, or a related discipline
Advanced degree is an advantage but not mandatory
Required Experience
Minimum 6–8 years of experience in Pharmacovigilance, with strong focus on ICSR Management
Demonstrated experience working with global safety databases (Argus strongly preferred)
Proven experience supporting clinical trial and post-marketing safety operations in a regulated environment
Required Skills and Competencies
Strong knowledge of Good Pharmacovigilance Practice (GVP), Good Clinical Practice (GCP), Clinical Trial Regulations (CTR), and global safety reporting requirements
In-depth understanding of adverse event reporting, medical and drug terminology, and pharmacovigilance methodologies
Hands-on experience with safety database configuration, case processing workflows, and coding conventions
Strong analytical, organizational, and time-management skills with the ability to prioritize competing demands
Excellent written and verbal communication skills
Ability to work effectively within a complex global matrix organization
Experience in vendor oversight and performance monitoring is highly desirable
Why Join GSK
GSK is united by a purpose to get ahead of disease together by combining science, technology, and talent. With a focus on specialty medicines and vaccines across respiratory, immunology, oncology, HIV, and infectious diseases, GSK offers the opportunity to work at global scale while making a meaningful impact on patient lives.
Employees benefit from competitive compensation, performance-based bonuses, flexible working options, continuous learning and career development, healthcare and wellbeing programs, and a strong culture of inclusion and accountability.
Inclusion and Equal Opportunity
GSK is committed to fostering an inclusive workplace and providing equal employment opportunities to all qualified candidates. Reasonable accommodations are available throughout the recruitment process upon request.
Important Notice
GSK does not charge any fees at any stage of the recruitment process. Candidates are advised to be cautious of fraudulent job postings or unsolicited communications not originating from official GSK email domains.
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