Experienced Medical Leadership Opportunity

1 day ago

Rajkot, Gujarat, India beBeeMedicalAdvisor Full time ₹ 20,00,000 - ₹ 25,00,000

Senior Medical Advisor Job Summary

We are seeking an accomplished medical professional to lead our team as a senior medical advisor/reviewer.

  • Lead medical monitoring efforts, ensuring effective communication with clients and sites.
  • Review study protocols, provide feedback, and ensure compliance.
  • Deliver therapeutic area training for the case processing team.
  • Draft medical monitoring plans (MMP) and ensure compliance.
  • Assess adverse events, determining appropriate actions and making SUSAR reportability assessments.
  • Perform clinical data reviews, ensure protocol compliance, and draft monthly reports for clients.
  • Develop and update training materials in line with GCP and GVP requirements.

Post-Marketing Responsibilities:

  • Support maintenance of the medical platform, including SOPs, manuals, and documents.
  • Lead and support medical reviewers.
  • Interact with client medical teams and clinical teams.
  • Act as the main responsible person at PLG for client concerns and escalations.
  • Perform medical reviews of ICSRs (e.g., Spontaneous, literature).
  • Conduct causality assessments, benefit-risk evaluations, and provide mentorship to junior medical reviewers.
  • Provide ongoing workshops and feedback to develop medical reviewers.
  • Participate in audits and inspections as required.
  • Ensure understanding of client needs and exceed expectations.
  • Train and mentor other team members.

Qualifications:

  • Leadership experience in medical review teams.
  • Client communications and safety database experience.
  • Minimum 10 years of experience working for service providers or pharmaceutical companies.
  • At least 5-7 years of experience as a Medical Monitor or clinical phase.

Key Skills:

  • Strong knowledge of GVP, GCP, FDA, and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.
  • Working knowledge of EDC systems.
  • Good medical knowledge and pharmacology understanding.

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