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Clinical Drug Safety Specialist

Clinical Drug Safety Specialist

beBeeSeniorMedicalExpertSurat, Gujarat, India
1 day ago
Job description

Senior Medical Expert

We are looking for a seasoned medical professional to lead our clinical and post-marketing drug safety efforts.

Clinical Phase :

  • Oversee medical monitoring teams and ensure effective communication with clients, sites, and other stakeholders.
  • Develop and implement medical monitoring plans (MMPs) that adhere to GCP and GVP requirements.
  • Review adverse events (AEs), assess their severity, and determine appropriate actions.
  • Collaborate with the clinical team to develop therapeutic area training materials.
  • Ensure compliance with regulatory requirements and provide support for investigator meetings and site queries.

Post-Marketing (Pharmacovigilance) :

  • Support the maintenance of medical platforms, SOPs, manuals, and documents.
  • Lead and mentor medical reviewers in their work, ensuring they meet client expectations.
  • Interact with clients' medical teams and clinical teams to address concerns and escalate issues as needed.
  • Perform medical review of ICSRs, including spontaneous and literature reports.
  • Conduct causality assessments, benefit-risk evaluations, and provide feedback on cases.
  • Requirements :

  • MBBS or MD (Doctor of Medicine)
  • Minimum 10 years of experience working in service providers or pharmaceutical companies
  • At least 5-7 years of experience as a Medical Monitor or in clinical phases
  • Excellent technical skills in Microsoft packages and EDC systems
  • Strong knowledge of GVP, GCP, FDA, and regulatory requirements related to drug safety
  • Key Responsibilities :

  • Develop and maintain relationships with clients and sites
  • Collaborate with cross-functional teams to achieve business objectives
  • Provide strategic guidance on medical review and pharmacovigilance activities
  • What We Offer :

  • Opportunities for growth and development
  • A collaborative and dynamic work environment
  • Competitive compensation and benefits package
  • How to Apply :

    Apply now by submitting your application, highlighting your relevant experience and qualifications.

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    Safety Specialist • Surat, Gujarat, India

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