Specialist – Pharmacovigilance Epidemiology & Risk Management
Company: Cencora (Affiliated Company: PharmaLex India Private Limited)
Location: Noida, Uttar Pradesh, India
Employment Type: Full-Time
Category: Consulting | Pharmacovigilance | Drug Safety
Job ID: R2519675
Posted Date: December 3, 2025
Experience Required: 3–6 years
Job Overview
Cencora is seeking a Specialist – Pharmacovigilance Epidemiology & Risk Management to support global drug safety operations through high-quality case processing, regulatory reporting, and risk management activities. This role is ideal for pharmacovigilance professionals with hands-on experience in ICSR processing, regulatory submissions, and quality assurance, who are looking to grow within a globally recognized healthcare organization.
The position is based in Noida, India, and offers exposure to global pharmacovigilance standards, regulatory authorities, and cross-functional collaboration.
Key Responsibilities
Perform triage and initial validity assessments of safety cases, including spontaneous reports, health authority cases, clinical trial cases, and literature cases.
Conduct initial ICSR assessments, including seriousness, expectedness, and reporting requirements.
Perform accurate and timely data entry into pharmacovigilance safety databases.
Evaluate the need for expedited reporting to health authorities and business partners, ensuring compliance with regulatory timelines.
Prepare and maintain regulatory reporting forms such as CIOMS I, MedWatch forms, and XML submissions.
Draft and send follow-up requests to collect missing or clarifying safety information.
Submit Individual Case Safety Reports (ICSRs) to global health authorities and client partners.
Ensure case completion and proper documentation in line with SOPs and regulatory expectations.
Conduct quality checks and quality assurance reviews of ICSRs to maintain data integrity and regulatory compliance.
Perform ICSR search and retrieval activities from the EudraVigilance (EVWEB) database, including company vs. non-company case assessments.
Mentor and support new team members, providing guidance on pharmacovigilance processes and fostering a collaborative learning environment.
Execute additional responsibilities as assigned by the supervisor in accordance with project and process requirements.
Required Qualifications & Experience
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Medicine, Nursing, or a related discipline.
3–6 years of experience in pharmacovigilance, drug safety, or ICSR case processing.
Strong working knowledge of global pharmacovigilance regulations and reporting requirements.
Hands-on experience with ICSR processing, expedited reporting, and regulatory submissions.
Familiarity with CIOMS, MedWatch, XML reporting, and safety databases.
Experience working with EudraVigilance (EVWEB) is preferred.
Strong attention to detail, analytical thinking, and documentation skills.
Ability to work effectively in a regulated, process-driven environment.
Excellent written and verbal communication skills.
What Cencora Offers
Opportunity to work with a global healthcare organization impacting patient safety worldwide.
Exposure to international pharmacovigilance projects and regulatory environments.
Competitive compensation aligned with local market standards.
Structured learning, mentoring, and career development opportunities.
Inclusive and collaborative work culture focused on professional growth and compliance excellence.
Equal Employment Opportunity
Cencora is an equal opportunity employer and is committed to providing a workplace free from discrimination and harassment. Employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, gender, sexual orientation, age, disability, veteran status, or any other protected status.
Reasonable accommodations are available for individuals with disabilities throughout the recruitment and employment process.
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