Clinical Drug Safety Specialist

4 days ago

Kollam, Kerala, India beBeeMedical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Medical Expert Lead

We are seeking a seasoned medical professional to lead our team in clinical and post-marketing drug safety. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in all aspects of medical monitoring.

  • Clinical Phase:
  • Develop and implement medical monitoring plans (MMPs) that ensure compliance with regulatory requirements.
  • Review and provide feedback on study protocols, identifying areas for improvement and ensuring seamless execution.
  • Deliver therapeutic area training to case processing teams, promoting expertise and efficiency.
  • Provide 24/7 support for client queries and protocol deviations, prioritizing patient safety.
  • Draft monthly reports detailing adverse events, assessing severity, and determining appropriate actions.
  • Evaluate SUSAR reportability, ensuring prompt and accurate response to regulatory agencies.
  • Perform data reviews, interpret clinical findings, and maintain protocol compliance.
  • Post-Marketing (Pharmacovigilance):
  • Spearhead the maintenance of our medical platform, including SOPs, manuals, and documents.
  • Lead and mentor medical reviewers, fostering growth and expertise within the team.
  • Collaborate with clients' medical and clinical teams to address concerns and escalate issues as needed.
  • Conduct medical reviews of ICSRs, assessing causality and benefit-risk evaluations for medicinal products.
  • Mentor junior medical reviewers, performing additional reviews to ensure competency and delivering ongoing workshops for skill development.
  • Participate in audits and inspections, guaranteeing understanding of client needs and expectations.

Required Education: Doctoral degree in Medicine or related field

Required Experience:

  • Leading medical review teams
  • Client communications
  • Safety Database experience
  • Minimum 10 years of experience in service providers or pharmaceutical companies
  • At least 5-7 years as a Medical Monitor or in clinical phases

Required Technical Skills:

  • Microsoft Office Suite
  • Strong understanding 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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