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Senior Specialist – Pharmacovigilance

2+ years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Full Time Education: Experience in pharmacovigilance literature screening and case processing. 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 – Pharmacovigilance

Location: Noida, India
Category: Consulting
Job Type: Full-time
Posted Date: August 27, 2025
Job ID: R2513656
Affiliated Company: PharmaLex India Private Limited
Employer: Cencora


About Cencora:

At Cencora, our team members are at the heart of everything we do. We are united by a shared responsibility to create healthier futures and improve the lives of people and animals everywhere. Join our innovative company and be part of a purpose-driven mission.


Position Summary:

The Senior Specialist Pharmacovigilance is responsible for scientific literature screening, safety case management, and ensuring compliance with pharmacovigilance regulations and client-specific requirements. This includes data entry, reporting, documentation, and interaction with EMA's Medical Literature Monitoring (MLM) service.


Key Responsibilities:

Literature Screening & Classification

  • Perform literature screening using internal search mechanisms and external tools/providers.

  • Classify safety-relevant publications and references.

  • Maintain records of internal literature ordering processes.

Safety Case Management

  • Enter literature case data into the safety database.

  • Prepare standard reporting forms (e.g., CIOMS I, MedWatch Forms, XML files).

  • Complete and document pharmacovigilance cases.

EMA MLM Monitoring

  • Download, review, and share Individual Case Safety Reports (ICSRs) from EMA’s MLM service.

  • Conduct duplicate searches of literature cases using updated MLM data.

Client & Project Management

  • Serve as the main point of contact for client and project-related communications.

  • Manage and monitor client expectations and project deliverables.

Cross-functional Collaboration

  • Support additional tasks across other service lines based on qualifications and training.

  • Undertake additional responsibilities as required and appropriate.


Qualifications & Skills:

  • Experience in pharmacovigilance literature screening and case processing.

  • Familiarity with regulatory reporting standards (CIOMS I, MedWatch, XML).

  • Knowledge of EMA Medical Literature Monitoring processes.

  • Strong organizational and data management skills.

  • Effective communication and client-facing abilities.


Benefits & Work Environment:

  • Benefit offerings may vary by country and will align with local market practices.

  • Eligibility and effective date for benefits may differ depending on role and location.

  • Committed to fostering a safe, respectful, and inclusive workplace culture.


Equal Opportunity Employer:

Cencora provides equal employment opportunities to all qualified individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. All employment decisions are based on merit, qualifications, and business needs.


Accessibility Support:

If you require accommodations during the employment application process, contact:
📞 888.692.2272
📧 hrsc@cencora.com
(Note: Only accommodation-related requests will be answered.)