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    Executive, Gpv Safety Operations, Pv

    Apotex
    1-5 years
    Not Disclosed
    Mumbai
    12 May 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Company: Apotex Inc.

    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 Apotex.

    Position: Pharmacovigilance Scientist

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

    Primary Responsibilities:

    • Conduct reviews of published literature to identify ICSRs and other events of special interest.
    • Develop and maintain SOPs.
    • Support PSRM activities by screening and identifying articles of interest for potential signals and 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 narrative compilation, MedDRA coding assessments, and causality assessments.
    • Submit ICSRs to regulatory authorities, Apotex affiliates, and business partners as per departmental SOPs and regulatory legislation.
    • Maintain departmental document management, including scanning and filing of source documents in accordance with SOPs.
    • Contribute to the maintenance and compliance oversight of PV processes, external service providers, and business partners.
    • Maintain user-level knowledge of ARGUS and MedDRA.
    • Develop and maintain PV agreements with business partners.
    • Perform safety data exchange reconciliation for external business partners, including compliance monitoring of reconciliation with business partners and its documentation.

    Supporting Responsibilities:

    • Provide relevant Argus module training and sign-off for new joiners within the department.
    • Work in a safe manner, collaborating as a team member to achieve all outcomes.
    • Demonstrate behaviors that exhibit our organizational values.
    • Ensure personal adherence to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
    • Perform all other relevant duties as assigned.

    Job Requirements:

    Education:

    • PharmD, MPharm, Nursing, or related Health Science discipline.

    Knowledge, Skills, and Abilities:

    • Excellent oral and written communication skills.
    • Knowledge of MedDRA, Oracle ARGUS, and online literature searching preferred.
    • Excellent organizational and interpersonal skills; experience in working in a dynamic team environment.
    • Excellent knowledge of relevant local and international regulations and ICH guidelines.
    • Advanced 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 and 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.

    Commitment to Diversity & Inclusion: 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 accommodation.

     

     

     

     

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