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 APIs, comprising Solid Dosage Formulations Active Pharmaceutical Ingredients.

Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively.

The manufacturing location at Mysore is spread over 69 acres and it’s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. 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 focusses on B2B model for EU, Canada and emerging markets.

Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. RD works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services.

JGL’s full-fledged Regulatory Affairs IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market.

Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18.

Kindly refer www.jubilantpharma.com for more information about organization.

JOB DESCRIPTION:

Accountabilities Scope Of Work

• Principle Accountabilities
• 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.
• Documentation
• 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.
• Statutory Compliances
• Maintain an awareness of current legislation associated withthe 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.