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    Pv Medical Writer Ii/Iii (Strong Aggregate Report Writing Experience Required)- Homebased In India

    Primevigilance
    0 -1 yrs. in PV / 1-2 yrs. in clinical practice years
    3 LPA to 5 LPA
    Pune
    Not Disclosed 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: 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: PV Medical Writer II/III (Strong Aggregate Report Writing Experience Required) - Home-based in India


    Location: Remote
    Type: Full-time
    Department: Medical Writing

    Company Description: PrimeVigilance, part of Ergomed PLC, 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 PrimeVigilance Medical Writer position offers a unique opportunity to further develop your career in the field of drug safety.

    Key Responsibilities:

    • Independent authoring, editing, and reviewing of various regulatory/clinical documents (e.g., aggregate reports, risk management plans) with responsibility for the quality and content of the document and compliance with internal and external standards.
    • Active participation in trainings and development, implementation, and maintenance of quality system documents for medical writing, including internal templates and formats required for standardized documentation.
    • Support in all pharmacovigilance operations associated with medical writing.
    • Continuous self-education in all aspects associated with medical writing.

    Qualifications:

    • Previous experience in pharmacovigilance medical writing, including PBRERs, DSURs, RMPs.
    • Medical or pharmaceutical degree, or equivalent life sciences degree.
    • Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
    • Advanced knowledge of English.

    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

    Come and join us in this exciting journey to make a positive impact on patients’ lives. We look forward to welcoming your application.

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