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.
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.
Accountabilities Scope of work
Perform literature search and identify the safety information present in the article with regard to Jubilant’s products
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
Timely allocation of ICSRs for data entry, quality review, medical review and its distribution in the safety database.
Preparation of PADERs and other aggregate reports as per the company’s SOP and regulatory guidelines.
Compilation of data and preparation of RMPs as per the company’s SOP and regulatory guidelines.
Timely updation of literature tracker as per the exclusion and inclusion criteria of the safety information.
Updating the QC checklist for the reviewed ICSRs on real time manner.
Archival of relevant documents and e-mail communications related to RMPs and update the RMP details in the RMP tracker.
Maintain an awareness of current legislation associated with the Worldwide Regulatory Pharmacovigilance requirements.
Ensures regulatory compliance by providing timely, quality information for the assigned activities following SOPs and regulations.
Timely completion of assigned trainings.