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Chief Medical Leader

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We are seeking a seasoned Medical Advisor to lead our clinical and post-marketing drug safety efforts.

Key Responsibilities:
  • Oversee medical monitoring experience, ensuring seamless communication with clients, investigator meetings, and site support regarding protocol or drug interactions.
  • Review study protocols, providing actionable feedback as needed.
  • Deliver therapeutic area training for the case processing team.
  • Draft medical monitoring plans (MMP) and ensure compliance.
  • Assess adverse events reported by study sites, determine severity, and take appropriate actions.
  • Makes assessments on SUSAR reportability.
  • Interpret clinical data, ensure protocol compliance, and draft monthly reports for clients.
Post-Marketing Expectations:
  • Sustain medical platforms including SOPs, manuals, and documents.
  • Lead and support medical reviewers.
  • Engage with client medical teams and clinical teams.
  • Act as the primary point of contact for client concerns and escalations.
  • Conduct medical reviews of ICSRs (e.g., spontaneous, literature).
  • Support causality, medical assessment, benefit-risk evaluation of medicinal products.
  • Mentor junior medical reviewers and perform additional review of cases.
  • Provide feedback and ongoing workshops to develop medical reviewers.