Assistant Manager - Noida - confidential

    confidential
    confidential Noida

    3 days ago

    Full time
    Description

    Responsible for the execution of operational tasks and all aspects of technical delivery and project management in the field of Literature Screening.

    Key Responsibilities:

    • Responsible for quality management, workload management, compliance
    • management and document management for the assigned PV projects.
    • Manages project coordination and resource allocation within the projects.
    • Train and mentor PV department staff, as needed.
    • Ensure monthly invoices are generated and shared for all PV clients on regular/monthly basis.
    • Responsible for recruitment of new staff in PV Department.
    • Is involved in objective setting and annual appraisals of staff.
    • Ensures training compliance for PV staff
    • Represents PV department during for-cause/maintenance client audits or regulatory authority inspections.
    • To write/ review QA documents such as SDEA s, Working Instructions, SOPs, Working
    • Procedures, templates, project metafiles etc for PharmaLex Pharmacovigilance projects.
    • To organize and perform training of the above-mentioned documents.
    • Identification (Classification of references) of safety- relevant publications in the scientific literature. Provision of scientific input during literature surveillance service.
    • Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers.
    • Medical assessment of literature reports into the safety database.
    • Act as main contact for client/project management.
    • The employee agrees to take over primary listed tasks and responsibilities in other service lines and additional reasonable tasks that align with their abilities, qualification and training, if required.

    Qualifications

    • Master s/Bachelor s degree in Pharmacy, Medicine, or a related field. Advanced degree preferred.
    • Minimum of 6-9 years of experience in pharmacovigilance.
    • Experience in handling pharmacovigilance activities for multiple countries.
    • Excellent communication and interpersonal skills with special focus on Quality
    • Ability to work effectively in a multicultural environment.
    • we'll versed with pharmacovigilance regulations and guidelines and updated with the latest developments in regulatory guidelines
    • Strong analytical and problem-solving skills.

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