Job Title:
Senior Specialist – Case Processing
Job Details:
Location: Noida, India
Category: Consulting
Job Type: Full-Time
Posted Date: August 29, 2025
Job ID: R2515961
Affiliated Company: PharmaLex India Private Limited
Work Mode: Remote/On-site (as applicable)
About Cencora:
At Cencora, our team members are at the center of everything we do. United by the purpose of creating healthier futures, we work collaboratively to improve the lives of people and animals across the globe. If you're passionate about making a meaningful impact in healthcare, we welcome you to join our innovative, mission-driven organization.
Position Overview:
The Senior Specialist – Case Processing will be responsible for managing and processing Individual Case Safety Reports (ICSRs) across various data sources including spontaneous, health authority, clinical trial, and literature reports. This role involves quality checks, documentation, expedited reporting, and mentorship within the pharmacovigilance process.
Key Responsibilities:
Case Processing & Safety Data Management
Perform triage and initial validity assessments for all case types: spontaneous, clinical trial, literature, and health authority reports.
Enter data into the pharmacovigilance (PV) database accurately and promptly.
Conduct initial assessment of ICSRs to determine seriousness and expectedness.
Evaluate whether expedited reporting is required, including assessment of regulatory timelines.
Prepare and submit standard reporting forms (e.g., CIOMS I, MedWatch, XML files).
Send follow-up requests to gather additional safety information as needed.
Submit ICSRs to Health Authorities and partners of the client.
Quality Assurance & Compliance
Conduct comprehensive quality checks of ICSRs to ensure compliance with:
Project-specific requirements
Industry standards
Regulatory guidelines
Maintain the accuracy, reliability, and completeness of safety data.
Retrieve and assess ICSRs from EVWEB database.
Perform company vs. non-company case assessments.
Mentoring & Team Support
Allocate cases and manage workload distribution across the team.
Provide system training and onboarding support to new team members.
Actively mentor and guide new joiners to ensure smooth integration and development.
Share best practices to maintain consistency and compliance.
Other Responsibilities
Perform additional duties as assigned by the supervisor according to evolving project requirements.
Qualifications:
Required:
Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, or related field.
3–5 years of experience in pharmacovigilance or drug safety, specifically in ICSR processing.
Proficiency in safety databases and tools (e.g., Argus, ARISg, or similar).
Strong knowledge of global pharmacovigilance regulations and guidelines.
Familiarity with MedDRA, WHO Drug Dictionary, and ICH E2B standards.
Attention to detail, time management, and multitasking capabilities.
Excellent written and verbal communication skills.
Preferred:
Prior experience in team mentoring or training.
Experience with EVWEB or similar literature monitoring systems.
Exposure to global safety case submission processes and systems.
What Cencora Offers:
Benefits and eligibility may vary by country and be aligned with local market practices.
Competitive salary package
Learning & development opportunities
Collaborative and inclusive work environment
Career growth across global functions
Compliance with local labor laws and benefit structures
Equal Employment Opportunity:
Cencora is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to:
Race, color, religion, sex, sexual orientation, gender identity
National origin, genetic information, age, disability, veteran status
Or any other protected category under applicable law
We are committed to providing reasonable accommodations for individuals with disabilities. To request an accommodation during the application process, contact:
📧 hrsc@cencora.com | ☎️ 888.692.2272
About Cencora:
Learn more about us at 🌐 www.cencora.com
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