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    Executive, GPV Safety Operations, PV - Mumbai, India - Apotex

    Apotex
    Apotex Mumbai, India

    4 days ago

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    Description

    About Apotex Inc.

    Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
    For more information visit: .

    Job Summary

    Global Pharmacovigilance (PV) is an operating department within Global R&D. The Global PV department is involved in the processing & submission of adverse drug reaction reports & safety data management to support the development & commercialization of Apotex products in the markets in which we do business, in compliance with global PV regulations & relevant ICH guidelines.

    Job Responsibilities

    Primary responsibilities

  • Conducts review of published literature hits to identify ICSRs & other events of special interest Develops & maintains SOPs
  • Support PSRM activity by screening & identifying articles of interest for potential signals & aggregate reports from published literature Embase hits
  • Perform precision-based data structured field, Quality reviews of ICSRs to ensure compliance with Apotex case processing conventions including, but not limited to, narrative compilation, MedDRA coding assessments & causality assessments
  • Perform submission of ICSRs to RA, Apotex affiliates & Business partners (BP) as per departmental SOPs & regulatory legislation
  • Maintain departmental document management, including scanning & filing of source documents in accordance with SOPs
  • Contribute to maintenance & compliance oversight of PV processes, external service providers & BPs
  • Maintains user-level knowledge of ARGUS & MedDRA
  • Develops & maintains PV Agreements with BPs
  • Perform Safety data exchange reconciliation for external BPs including compliance monitoring of reconciliation with BPs,& its documentation

    • Supporting responsibilities

  • Imparts relevant Argus module training & sign off of new joinees within department
  • Works in a safe manner collaborating as a team member to achieve all outcomes
  • Demonstrate Behaviours that exhibit our organizational Values
  • Ensure personal adherence with all compliance programs including the Global Business Ethics & Compliance Program, Global Quality policies & procedures, Safety & Environment policies & HR policies
  • All other relevant duties as assigned

    • Job Requirements

  • Education D, MPharm, Nursing or related Health Science discipline
  • Knowledge, Skills & Abilities Excellent oral/written communication skillsKnowledge of MedDRA, Oracle ARGUS & online literature searching preferredExcellent organizational & interpersonal skills; experience in working in a dynamic team environmentExcellent knowledge of relevant local & international regulations & ICH guidelinesAdvanced knowledge of Microsoft Office: Excel, PowerPoint, Word
  • Experience Core PV experience across safety operations: at least 2-3 years pharmaceutical experience in a PV role Quality Review & Submissions: Preferred experience of at least 1-2 years on submission of ICSRs globally Literature Validation: Preferred experience of at least 1-2 years on literature validation/ case processing

    • At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

    Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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