Sr Executive-Pharmacovigilance(Signal Mgmt)
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 & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients.
Manages and tracks Signal Management Activities collaborating with colleagues and documentation of important and potential risks/Emerging safety issues for continuity of safety surveillance activities.
Coordination of Signal Assessment Activities with functional head/team leads including compiling source data, scientific interpretation and presentation of data for analysis.
Preparing signal evaluation reports along with quality control and medical assessment under the stipulated review period for all the company molecules that provide the basis and analysis for potential labeling changes to the reference safety information if applicable.
Leads efforts in strategy & research of literature and drug databases and compiles source data for aggregate review in evaluation of signals.
Contributes to the overall assessment of benefit/risk analysis from risk characterization of marketed products through surveillance and Signal Management Activities.
Ensure regulatory compliance by providing timely, quality information for signal review following SOPs and regulations. Must have worked with Product based Organization.
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