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Senior Specialist – Case Processing

3–5 years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Remote Education: Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, or related field. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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