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    Pharmacovigilance Scientist

    Boehringer Ingelheim
    2+ years
    Not Disclosed
    United Kingdom
    10 Dec. 6, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Position: Pharmacovigilance Specialist
    Company: Boehringer Ingelheim UK
    Location: United Kingdom

    Basic Purpose of the Job

    As a Pharmacovigilance Specialist, you will ensure the efficient and compliant operation of the Boehringer Ingelheim (BI) UK Pharmacovigilance (PV) system. This includes maintaining 100% compliance with adverse event reporting timelines, managing data quality, and supporting business objectives through timely, precise task execution. All work must align with BI policies, regulatory standards, and legal requirements.

    Key Accountabilities

    Adverse Event Reporting & Compliance

    • Ensure 100% compliance with internal and regulatory reporting timelines for adverse event/reaction cases.
    • Process Individual Case Safety Reports (ICSRs) accurately and in line with BI procedures and timelines.
    • Request and document follow-up information using tools like the Product Quick Guide and query reports.

    Pharmacovigilance System Maintenance

    • Oversee areas such as Literature Review, Malta Legislation Monitoring, Contingency Planning, and timely updates to Working Instructions and PV Repository.
    • Maintain inspection readiness by ensuring compliance with company procedures, regulations, and legislation.

    Cross-Functional Collaboration & Support

    • Develop strong relationships with business partners, offering guidance on navigating PV-relevant procedures.
    • Provide accurate advice and training on PV processes, including Investigator-Initiated Studies (IIS) and other projects.
    • Handle communications with business partners, external customers, and Health Authorities promptly and professionally.

    Process Improvement & Inspection Readiness

    • Lead or contribute to process improvement initiatives to enhance PV system efficiency.
    • Ensure readiness for inspections by maintaining compliance with all PV-related systems and processes.

    Regulatory and Organisational Knowledge

    • Basic understanding of European and international PV regulations and laws.
    • Thorough knowledge of UK, Ireland, and Malta regulatory requirements and ICH-GCP standards.
    • Minimum of 2 years' experience in pharmacovigilance or equivalent within the pharmaceutical industry.
    • Knowledge of PV systems, processes, and compliance requirements.
    • Proficiency in BI systems and applications related to the role.

    Required Skills and Competencies

    • Collaborative mindset with a focus on teamwork and knowledge sharing.
    • Ability to provide constructive feedback and propose process improvements.
    • Strong negotiation and compromise skills to maintain positive relationships.
    • Excellent written and verbal communication tailored to the audience's level of expertise.
    • Organizational and interpersonal skills, with the ability to prioritize tasks effectively.
    • Proficiency in database management and Microsoft Office applications (Excel, Word, Outlook).

    Qualifications

    • Education: Life Science degree or equivalent.
    • Experience:
      • Prior experience in pharmacovigilance and compliance with regulatory requirements (essential).
      • Understanding of the business impact of pharmacovigilance functions.

    Why Join Boehringer Ingelheim?

    Boehringer Ingelheim is a global leader in developing breakthrough therapies for humans and animals. As a family-owned company founded in 1885, we take a long-term perspective and foster a collaborative and innovative culture. With 52,000 employees worldwide, we provide opportunities to grow, collaborate, and make a meaningful impact on patients' lives.

    • Challenging work in a supportive and inclusive environment.
    • Continuous learning and development opportunities.
    • A commitment to diversity, equity, and inclusion.

    Application Process

    1. Visit the company website to apply.
    2. Create an account or sign in to upload your resume and register your profile.

    For additional questions or technical issues:

    Equal Opportunity Employer
    Boehringer Ingelheim is committed to maintaining a diverse and inclusive environment. All qualified candidates will be considered regardless of race, gender, disability, or other protected statuses.

    To learn more, visit: Boehringer Ingelheim Careers.

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