Job Summary
Cencora is looking for a Senior Specialist – Case Processing (PER) to join its pharmacovigilance team in Noida, India. The role involves leading case triage, ICSR assessment, expedited reporting, and quality checks while mentoring new team members. This is a full-time, on-site role offering an opportunity to contribute to global drug safety and compliance.
Key Responsibilities
Perform triage and initial validity assessments for cases, including spontaneous, literature, and clinical trial cases.
Enter safety data into pharmacovigilance (PV) databases accurately.
Conduct initial ICSR assessment and evaluate expedited reporting requirements to health authorities.
Prepare CIOMS I / MedWatch forms and XML safety data files.
Handle follow-up requests and submission of ICSRs to regulatory agencies and partners.
Perform quality checks of ICSRs to ensure compliance with PV guidelines and project requirements.
Execute ICSR searches/retrievals from EVWEB database and conduct company/non-company case assessments.
Manage allocation of case workloads within the team.
Train team members on PV systems and mentor new joiners to ensure smooth integration.
Actively participate in continuous improvement and internal process optimization.
Required Skills & Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
Strong knowledge of MedDRA coding, ICH-GCP, GVP guidelines, and case processing workflows.
Hands-on experience with PV databases (e.g., Argus, ARISg, or similar).
Familiarity with CIOMS and MedWatch reporting standards.
Strong quality focus and attention to detail.
Ability to train and mentor team members effectively.
Excellent communication and organizational skills.
Previous experience in case triage and ICSR review (2–5 years preferred).
Perks & Benefits
Competitive salary package (as per industry standards).
Opportunity to work on global drug safety projects.
Career growth through mentoring and leadership opportunities.
Training on advanced PV tools and systems.
Collaborative, knowledge-driven workplace culture.
Company Description
Cencora, through its affiliate PharmaLex India Private Limited, is a global healthcare consulting leader providing services in drug safety, pharmacovigilance, and risk management. With a strong focus on patient safety and regulatory compliance, Cencora supports life sciences companies worldwide in bringing safe and effective products to market.
Work Mode: On-site – Noida, India
Employment Type: Full-time
Call-to-Action
Take the next step in your pharmacovigilance career. Apply today to join Cencora as a Senior Specialist in Case Processing and contribute to global drug safety initiatives.
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