Senior Clinical Specialist

6 days ago


Hubli, Karnataka, India beBeeMedical Full time ₹ 10,00,000 - ₹ 15,00,000

Key Responsibilities:

  • Lead as a medical monitor/Medical expert in clinical and post-marketing drug safety.
  • Review and provide feedback on study protocols, draft medical monitoring plans (MMP), and ensure compliance.
  • Deliver therapeutic area training for all case processing team and mentor junior medical reviewers.

Clinical Phase:

  • Effectively communicate with clients, attend investigator meetings, and provide support to sites regarding protocol or possible drug interactions.
  • Assess severity of adverse events (AEs) reported by study sites and determine appropriate actions.
  • Make assessments on SUSAR reportability and perform review and interpret clinical data.

Post-Marketing (Pharmacovigilance):

  • Support maintenance of medical platform including SOPs, manual, and documents.
  • Lead and support the medical reviewers, interact with clients' medical team and clinical team.
  • Act as main responsible person at PLG for clients' concerns and escalation.

Requirements:

  • MBBS or MD (Doctor of Medicine).
  • Minimum 10 years experience working for service providers or pharmaceutical company.
  • At least 5-7 years of experience as a Medical Monitor or clinical phase.

Technical Skills:

  • Microsoft package.
  • Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.


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