Pharma Vigilance Consultant

1 month ago

Pune, Maharashtra, India Capgemini Engineering Full time

Job Summary:

The Pharma Vigilance Consultant at Capgemini Engineering is responsible for overseeing and managing pharmacovigilance activities to ensure compliance with regulatory requirements and to enhance the safety profile of pharmaceutical products. This role involves analyzing adverse drug reactions (ADRs), managing risk assessments, and providing strategic guidance to ensure patient safety and regulatory adherence.

Key Responsibilities:

  • Adverse Event Management:
    • Collect, evaluate, and report adverse drug reactions (ADRs) and other safety-related data.
    • Perform signal detection and risk assessment using pharmacovigilance databases and tools.
    • Ensure timely and accurate submission of safety reports to regulatory authorities.
  • Regulatory Compliance:
    • Maintain up-to-date knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
    • Ensure compliance with global pharmacovigilance regulations and internal policies.
    • Assist in the preparation and submission of regulatory documents related to safety.
  • Safety Risk Management:
    • Develop and implement risk management plans and strategies to mitigate potential risks associated with pharmaceutical products.
    • Conduct benefit-risk assessments and provide recommendations for risk mitigation.
  • Documentation and Reporting:
    • Prepare detailed safety reports, including Periodic Safety Update Reports (PSURs) and Risk Evaluation and Mitigation Strategies (REMS).
    • Maintain accurate and comprehensive records of safety data and regulatory submissions.
  • Training and Support:
    • Provide training and guidance to internal teams on pharmacovigilance processes and best practices.
    • Offer support to clinical and medical teams regarding safety issues and regulatory requirements.
  • Stakeholder Communication:
    • Serve as a liaison between regulatory authorities, healthcare professionals, and internal teams on safety-related matters.
    • Address and resolve safety concerns or queries from stakeholders.
  • Continuous Improvement:
    • Identify areas for improvement within pharmacovigilance processes and implement enhancements.
    • Stay abreast of industry trends and advancements in pharmacovigilance practices.

Qualifications:

  • Experience: Minimum 8 years of experience in pharmacovigilance, clinical trials, or a related field. Experience with safety databases and regulatory submissions is highly desirable.
  • Skills:
    • Strong knowledge of pharmacovigilance regulations and practices.
    • Excellent analytical and problem-solving skills.
    • Proficiency in pharmacovigilance software and databases.
    • Effective communication and interpersonal skills.
    • Ability to work independently and manage multiple projects simultaneously.

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