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    Pv Associate/Literature

    Primevigilance
    0 -1 yrs. in PV / 1-2 yrs. in clinical practice years
    3 LPA to 5 LPA
    Pune
    10 July 10, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, 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

    Title: PV Associate/Literature
    Location: Pune, India
    Type: Full-time
    Department: Literature

    Company Description: PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. We have achieved global organic growth, with staff based across Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance supports small to large pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming a global leader in its field, covering all therapy areas including medical devices.

    Job Description: The PV Associate/Literature position involves assuring and exerting activities leading to effective cooperation with clients in the area of literature monitoring. The role ensures that literature screening responsibilities and activities are managed in a cost-efficient manner of the highest quality and in compliance with global regulations and company policies, and in accordance with any Pharmacovigilance (PV) agreement.

    Responsibilities:

    • Assist with the development of literature search strategies.
    • Participate in weekly and ad hoc literature screening activities to identify potential ICSRs and other relevant safety-related information pertaining to nominated products.
    • Assist with ordering copies of full literature articles for review.
    • Maintain a record and track all literature abstracts screened and full literature articles reviewed, with actions taken and the reason.
    • Forward any ICSRs to PV Associates for data entry into the global drug safety database.
    • File other relevant safety-related information for use in signal detection and PSURs.
    • Participate in the screening of local non-indexed literature as required.
    • Assist in peer review QC of abstracts.

    Qualifications:

    • Life science or biomedical background – healthcare-related degree (chemistry, biology, biotechnology, veterinary science); previous experience is not required.
    • Time and issue management, delegation, organization, and multitasking skills with good attention to detail.
    • Strong interpersonal and communication skills.
    • Advanced English skills, both verbal and written (at least B2 level).

    Additional Information:

    Why PrimeVigilance? We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow. Our people are our greatest strength, leading to our continued success in improving the lives of those around us.

    We Offer:

    • Training and career development opportunities internally.
    • Strong emphasis on personal and professional growth.
    • Friendly, supportive working environment.
    • Opportunity to work with colleagues based all over the world, with English as the company language.

    Our Core Values:

    • Quality
    • Integrity & Trust
    • Drive & Passion
    • Agility & Responsiveness
    • Belonging
    • Collaborative Partnerships

    We look forward to welcoming your application.

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