Executive-Pharmacovigilance
, MD, United States
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.
Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sitedat Roorkee, Uttarakhand and Salisbury, Maryland, USAengaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets.
Case processing / data entry and related activities in the Argus safety database as per DE conventions within specified timelines.
Participate in downloading, triaging, uploading and book-in of regulatory and EMA MLM ICSR reports.
Participate in triaging and book-in of literature reports.
Triage, Case book-in, data entry & archiving.
Ensure use of PV-MedDRA for coding adverse reactions
Documentation
Ensure that pharmacovigilance SOPs, procedures, processes, and guidelines are adhered to communicate with external and internal customers in a timely manner, as per the requirement.
Statutory Compliances
Maintain an awareness of current legislation associated withthe Worldwide Regulatory Pharmacovigilance requirements.
Ensures regulatory compliance by providing timely, quality information for aggregate reports and signal review following SOPs and regulations.
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