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    Deputy Manager

    Lambda Therapeutic Research
    5+ years
    Not Disclosed
    Ahmedabad
    10 Dec. 19, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Deputy Manager
    Location: Ahmedabad, India
    Company: Lambda Therapeutic Research Ltd.
    Date: Dec 11, 2024

    Organizational Overview

    Lambda Therapeutic Research Ltd. is a leading global Clinical Research Organization (CRO) providing comprehensive services to the biopharmaceutical and generic industries. With over 20 years of experience, Lambda operates in several locations worldwide, offering cutting-edge clinical trial solutions to help clients develop products safely, efficiently, and with a commitment to quality.

    Job Details

    The Deputy Manager in the Pharmacovigilance Department is responsible for providing expert pharmacovigilance guidance to both clients and colleagues, ensuring that all activities are performed in line with regulatory requirements, internal SOPs, and industry guidelines. This role also involves leading and supporting the pharmacovigilance team, overseeing medical assessments of adverse events, and contributing to the ongoing improvement of safety processes.

    Key Responsibilities

    • Pharmacovigilance Support: Provide expert pharmacovigilance advice and ensure compliance with SOPs, regulations, and guidelines.
    • Medical Leadership: Lead the medical assessment of adverse events, evaluate causality, and participate in the follow-up of safety issues related to clients' products.
    • Team Support & Management: Mentor and support the pharmacovigilance team, train new team members, and ensure proper work allocation and task management for compliance.
    • Regulatory Intelligence: Stay informed on changes to local and national pharmacovigilance regulations and ensure they are implemented effectively.
    • Quality Assurance: Conduct thorough evaluations of adverse events, review data entry, drug coding, and MedDRA coding, ensuring adherence to internal SOPs and external regulatory standards.
    • Continuous Improvement: Contribute to the development of SOPs and process enhancements to improve pharmacovigilance operations and ensure timely submission of ICSR reports.
    • Client Communication: Provide high-quality communication with clients and regulatory authorities regarding safety issues, inquiries, and safety responses.
    • Training and Development: Ensure proper training for new team members and provide ongoing development for the pharmacovigilance team.

    Key Deliverables

    • Ensuring compliance with pharmacovigilance regulations and company standards
    • Accurate and timely assessment of adverse events and causality
    • Effective management of pharmacovigilance team and task allocation
    • Support for regulatory submissions and safety responses
    • Training and mentoring of new team members

    Allied Responsibilities

    • Contribute to the continuous improvement of pharmacovigilance processes
    • Ensure high standards in communication with all internal and external stakeholders
    • Support the timely and accurate submission of reports to regulatory authorities

    Experience

    • Minimum 5+ years in pharmacovigilance with prior team handling experience.

    Educational Qualifications

    • MBBS / MD in Pharmacology or related fields.

    Competencies

    • Accountability and strong work ethic
    • Effective communication and leadership skills
    • Initiative in planning and organizing tasks
    • Ability to foster team motivation/initiative
    • High technical knowledge in pharmacovigilance
    • Strong interpersonal and presentation skills

    Why Join Us?

    Lambda Therapeutic Research is a place where you can make a tangible impact on the world of clinical trials. If you are passionate about pharmacovigilance, have the expertise in managing teams, and want to contribute to the safety and compliance of clinical products, join us to work alongside experienced professionals and grow in a supportive and dynamic environment.

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