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Medical Director - Clinical Safety

Medical Director - Clinical Safety

beBeeClinicalSafetyKochi, Kerala, India
19 hours ago
Job description

Senior Clinical Safety Expert

We are seeking a seasoned medical professional to lead our clinical and post-marketing drug safety initiatives. This role requires expertise in all aspects of clinical trials, including protocol development, monitoring, and reporting.

Clinical Phase :

  • Lead as a medical monitor / Medical expert
  • Collaborate with clients to ensure compliance with regulatory requirements.
  • Develop and deliver therapeutic area training for case processing teams.
  • Draft medical monitoring plans (MMP) and review adverse event reports.

Post-Marketing (Pharmacovigilance) :

  • Maintain medical platforms, including SOPs, manuals, and documents.
  • Support and mentor junior medical reviewers.
  • Review ICSRs, perform causality assessments, and evaluate benefit-risk.
  • Participate in audits and inspections as required.
  • Requirements :

    MBBS or MD degree, 10+ years of experience, and expertise in GVP, GCP, and FDA regulations.

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    Director Clinical • Kochi, Kerala, India

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