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    Benefit/Risk Officer (Pharmacovigilance)

    Primevigilance
    0-1 years years
    2-4 LPA
    Pune
    10 July 10, 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, 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

    Title: Benefit/Risk Officer (Pharmacovigilance)


    Location: Pune, Maharashtra, India
    Type: Full-time
    Department: Benefit-Risk Management

    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, providing 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 Benefit/Risk Officer will have a life science or biomedical background, preferably a pharmacist, with experience in signal detection and the use of signal management tools. Working as part of a project team, the Benefit/Risk Officer will perform and support contracted pharmacovigilance activities on behalf of PrimeVigilance.

    Responsibilities:

    • Participate in signal detection activities, including setup.
    • Review line listings required for the preparation of signal detection reports.
    • Draft complex signal detection reports, including quality control.
    • Evaluate and categorize potential signals.
    • Propose a course of action whenever a potential signal is identified.
    • Provide support for the preparation of communication with regulatory authorities.
    • Record keeping and maintenance of relevant tracking tools.
    • Work with other company departments to ensure that signal management is conducted in accordance with PrimeVigilance procedures and regulatory requirements.

    Qualifications:

    • Life science or biomedical background, preferably pharmacy.
    • Previous experience in signal detection and use of signal management tools.
    • Excitement to learn and contribute to patient safety.
    • 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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