Job Title: Manager – Case Processing
Location: Bengaluru, India
Employment Type: Full-Time
Experience Level: Senior / Managerial
Department: Pharmacovigilance
Job Overview
The Manager – Case Processing oversees end-to-end pharmacovigilance operations, with a strong focus on Individual Case Safety Reports (ICSR) and literature monitoring. The role involves managing teams, ensuring compliance with regulatory guidelines, maintaining quality deliverables within defined SLAs, and driving continuous process improvement and operational excellence.
Key Responsibilities
1. Operational Oversight
Demonstrate comprehensive understanding of ICSR and literature monitoring processes, including all relevant global regulatory guidelines (ICH-GCP, GVP, 21 CFR, etc.).
Guide and support Team Leads and Subject Matter Experts (SMEs) in operational and domain-related activities.
Allocate and assign tasks to team members to meet deliverables, SLAs, and KPIs efficiently.
Monitor team performance to ensure all goals such as utilization, efficiency, and quality metrics are achieved.
Collaborate with clients and internal teams to identify, mitigate, and escalate project risks and ensure timelines are met.
2. Team & Performance Management
Conduct performance management reviews and mentor team members for career and skill development.
Lead training and capability development initiatives for team members and leads to strengthen functional expertise.
Deliver process-specific and refresher trainings as per project or organizational needs.
Foster a culture of continuous improvement, encouraging proactive problem-solving and innovation.
3. Quality & Process Enhancement
Identify opportunities to improve process efficiency, quality, and compliance within ICSR workflows.
Contribute to the enhancement of client and internal project workflows, ensuring alignment with industry standards.
Develop, update, and maintain departmental SOPs and work instructions, and provide related training.
Ensure adherence to quality systems and audit readiness across all pharmacovigilance processes.
Required Expertise
Technical & Functional Knowledge
In-depth understanding of:
ICSR processing (serious, non-serious, and potentially serious cases).
Sources such as spontaneous, solicited, literature, clinical trials, and regulatory authority reports.
MedDRA coding, GVP modules, and global safety regulations.
Experience managing high ICSR volumes and handling fluctuating workloads effectively.
Hands-on experience with MS Office applications and pharmacovigilance databases.
Leadership & Project Management
Proven people management and mentoring abilities.
Skilled in project management, client communication, and cross-functional collaboration.
Experience leading rare disease and oncology case processing teams (preferred).
Experience with literature review processes (added advantage).
Candidate Profile
Education: Master’s degree or higher in Life Sciences, Pharmacy, or Medicine.
Experience: 10–12 years of relevant experience in Pharmacovigilance / Case Processing or related domains.
Core Competencies:
Leadership and mentoring abilities.
Strategic resource allocation and project oversight.
Strong analytical and decision-making skills.
Excellent communication, client engagement, and reporting proficiency.
Commitment to quality, compliance, and operational excellence.
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