Are you a passionate graduate in B. Pharma, M. Pharma, or B. Sc. Lifescience looking to make a significant impact in the pharmaceutical industry? Look no further! Jubilant Generics Limited, a leading pharmaceutical company, is actively seeking talented individuals like you to join our team as Executive/Sr. Executive – Pharmacovigilance. Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics Solid Dosage Formulations.
Position |
Executive / Sr. Executive – Pharmacovigilance |
Department |
Pharmacovigilance |
Salary |
Competitive |
Essential Qualification |
UG: Bachelor’s degree in Life Sciences, Pharmacy, or related field PG: Master’s degree in Pharmacovigilance or equivalent |
Work Location |
Greater Noida, Uttar Pradesh |
Key Skills |
Pharmacovigilance, Safety Information, ICSR, Data Entry, Quality Review, Medical Review, PADERs, Aggregate Reports, RMPs, Literature Tracker, QC Checklist, Regulatory Compliance, Training |
KEY ACCOUNTABILITIES:
Accountabilities Scope of work
1. Principle Accountabilities
2. Perform literature search and identify the safety information present in the article with regard to Jubilant’s products
3. Perform quality check of the ICSR in the safety database to ensure accurate and consistent data entry and processing from adverse event reports/source document following the Company’s Data Entry Conventions.
4. Timely allocation of ICSRs for data entry, quality review, medical review and its distribution in the safety database.
5. Preparation of PADERs and other aggregate reports as per the company’s SOP and regulatory guidelines.
6. Compilation of data and preparation of RMPs as per the company’s SOP and regulatory guidelines.
Documentation
1. Timely updation of literature tracker as per the exclusion and inclusion criteria of the safety information.
2. Updating the QC checklist for the reviewed ICSRs on real time manner.
3. Archival of relevant documents and e-mail communications related to RMPs and update the RMP details in the RMP tracker.
Statutory Compliances
1. Maintain an awareness of current legislation associated with the Worldwide Regulatory Pharmacovigilance requirements.
2. Ensures regulatory compliance by providing timely, quality information for the assigned activities following SOPs and regulations.
3. Timely completion of assigned trainings.
How to Apply
To apply for this exciting opportunity with Jubilant Generics Limited,
“Application for Executive / Sr. Executive – Pharmacovigilance.”
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