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    Executive - Pharmacovigilance Pv Psrm

    Apotex
    2-3 years years
    Preffered by Company
    Mumbai
    Not Disclosed July 9, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm, M.Pharm, PharmD, Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in Dentistry or Bachelor degree in Veterinary Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Executive - Pharmacovigilance PV PSRM

    Date: July 6, 2024
    Location: Mumbai, MH, IN, 400083
    Company: Apotex

    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. The Apotex group focuses on the development and sale of generic, biosimilar, and specialty products through vertical integration.
    For more information, visit: www.apotex.com.

    Job Summary

    The Executive - Pharmacovigilance PV PSRM prepares periodic safety update reports (PSURs/PBRERs) in compliance with drug safety regulations and ICH Guidelines. The role involves using medical judgment to analyze and evaluate adverse reports, resolving causality assessment queries, and liaising with reporting sites. Additionally, the position participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities.

    Job Responsibilities

    Primary Responsibilities

    • Prepare periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.
    • Maintain current awareness of safety issues on Apotex products through ongoing monitoring and literature review, demonstrating scientific skills in research, analysis, and interpretation of safety data.
    • Prepare responses to complex queries and requests for safety information from internal customers (RA, QA, NPD project teams, etc.).
    • Ensure adherence to compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.

    Additional Responsibilities

    • Develop and maintain Standard Operating Procedures (SOPs).
    • Develop and maintain training documents and track compliance of internal and external global partners involved in drug safety reporting.
    • Maintain user-level knowledge of Oracle ARGUS and MedDRA terminology.
    • Work as a team member to achieve all outcomes.
    • Deliver work in support of Apotex values: Collaboration, Courage, Perseverance, and Passion.
    • Perform other duties as assigned.

    Supporting Responsibilities

    • Provide input and feedback to departmental process improvement strategy discussions.
    • Contribute to creating and promoting an environment of teamwork, ensuring excellence in customer service through timely delivery of quality drug safety data.
    • Liaise regularly and develop strong working relationships with external partners and international Apotex affiliates, demonstrating corporate values in work performance and interactions.
    • Interact with other internal departments when necessary.
    • Contribute to the interpretation of PV regulations and apply sound decisions related to regulatory guidelines and policies.
    • Show initiative to remain current on new PV regulations and international guidelines, seeking guidance from Group Leader and management to enhance knowledge.
    • Perform all work in accordance with established ICH guidelines, regulatory compliance, and safety requirements, maintaining current knowledge of relevant Pharmacovigilance regulations.

    Job Requirements

    Education

    • Physicians, Pharm.D, M Pharm, Nursing, or related Health Science discipline

    Knowledge, Skills, and Abilities

    • Excellent analytical and problem-solving skills
    • Excellent oral and written communication in English
    • Knowledge of MedDRA, Oracle ARGUS, and online literature searching (preferred)
    • Excellent organizational and interpersonal skills; experience in a dynamic team environment
    • Excellent knowledge of local and international regulations and ICH guidelines on safety data management in clinical trials and post-approval
    • Advanced knowledge of Microsoft Office: Excel, PowerPoint, Word

    Experience

    • Core PV experience with at least 2-3 years of pharmaceutical experience
    • Preferred experience of at least 1-2 years in periodic reviews on aggregate safety data

    Inclusion and Accommodation

    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 for an interview or testing, please advise us if you require accommodation.

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