Specialist – Pharmacovigilance Epidemiology & Risk Management
Company: Cencora (Affiliated Company: PharmaLex India Private Limited)
Location: Noida, Uttar Pradesh, India
Job Category: Consulting | Pharmacovigilance
Job Type: Full-Time
Job ID: R2519675
Posted On: 03 December 2025
Experience Required: 3–6 years in Pharmacovigilance / Drug Safety
About the Company
Cencora is a global healthcare organization dedicated to creating healthier futures for people and animals worldwide. Driven by innovation, collaboration, and a strong sense of responsibility, Cencora empowers its employees to make a meaningful impact across the healthcare ecosystem.
Job Overview
Cencora is seeking a Specialist – Pharmacovigilance Epidemiology & Risk Management to join its consulting team in Noida, India. The role focuses on end-to-end Individual Case Safety Report (ICSR) management, regulatory compliance, and quality assurance across global pharmacovigilance projects.
This position is ideal for experienced pharmacovigilance professionals with strong knowledge of global safety reporting requirements and hands-on experience with safety databases.
Key Responsibilities
Perform triage and initial validity assessment of ICSRs, including spontaneous, clinical trial, literature, and health authority cases.
Conduct initial ICSR assessments and evaluate the requirement for expedited reporting to health authorities and client partners, ensuring adherence to regulatory timelines.
Perform data entry and case processing within pharmacovigilance safety databases.
Prepare and submit regulatory reporting forms, including CIOMS I, MedWatch forms, and XML files.
Manage follow-up requests with reporters, affiliates, and partners to ensure complete and accurate case data.
Submit ICSRs to global health authorities and client partners in accordance with applicable regulations.
Ensure case completion, documentation, and archival in compliance with internal SOPs and regulatory standards.
Conduct quality checks and quality assurance reviews of ICSRs to maintain data integrity, accuracy, and regulatory compliance.
Perform ICSR search and retrieval activities from the EudraVigilance (EVWEB) database, including company and non-company case assessments.
Support and mentor new team members, providing guidance on processes, tools, and regulatory requirements to promote team integration and professional development.
Execute additional responsibilities as assigned by the supervisor in line with project and process requirements.
Required Qualifications & Experience
Bachelor’s degree in Pharmacy, Life Sciences, Nursing, Medicine, or a related discipline.
3–6 years of hands-on experience in pharmacovigilance or drug safety operations.
Strong understanding of ICSR processing, expedited reporting, and global PV regulations, including ICH, GVP, EMA, and FDA guidelines.
Practical experience with safety databases and regulatory submission platforms.
Proven ability to prepare and submit CIOMS, MedWatch, and XML reports.
Experience in quality review and compliance checks within pharmacovigilance workflows.
Strong attention to detail, analytical skills, and ability to manage multiple cases within defined timelines.
Excellent written and verbal communication skills with the ability to collaborate in a global, cross-functional environment.
What Cencora Offers
Competitive compensation aligned with local market standards.
Comprehensive benefits package (country-specific).
Exposure to global pharmacovigilance and consulting projects.
Opportunities for continuous learning, professional growth, and career advancement.
Inclusive, ethical, and performance-driven work culture.
Equal Employment Opportunity
Cencora is an equal opportunity employer and is committed to maintaining a workplace free from discrimination and harassment. Employment decisions are based on merit, qualifications, and business needs, without regard to race, color, religion, gender, sexual orientation, gender identity, age, disability, veteran status, or any other protected status.
Reasonable accommodations are available for individuals with disabilities during the recruitment process, in accordance with applicable laws.
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