Executive-Pharmacovigilance

5 days ago

Greater Noida, Uttar Pradesh, India Jubilant Generics Limited Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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 and Allergy Therapy Products, and Generics and APIs, comprising Solid Dosage Formulations and Active Pharmaceutical Ingredients.

Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research and 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. R and D 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 and 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 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year

Kindly refer for more information about organization.

JOB RESPONSIBILITIES:

;;;;;;;;;;;;Accountabilities ;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;; Scope of work

  • Principle Accountabilities

  • 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 and 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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