Senior Clinical Safety Lead

3 days ago

Kozhikode, Kerala, India beBeeMedical Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Title: Medical Advisor

We are seeking a seasoned medical professional to lead our clinical and post-marketing drug safety initiatives.

  • Lead as a medical monitor/Medical expert in clinical phase projects.
  • Medical monitoring experience is essential, with the ability to effectively communicate with clients, attend investigator meetings, and provide support to sites regarding protocol or possible drug interactions.
  • Review and provide feedback on study protocols as needed.
  • Deliver therapeutic area training for all case processing team members.
  • May require 24/7 availability depending on client needs for possible queries or protocol deviations resulting in potential harm to patients.
  • Drafting medical monitoring plans (MMP) and ensuring compliance.
  • Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation).
  • Make assessments on SUSAR reportability.
  • Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for the clients (with presentation at periodic meetings if required).
  • Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.
Post-Marketing (Pharmacovigilance)
  • Support in maintenance of medical platform including SOPs, manual and documents.
  • Lead and support the medical reviewers.
  • Interaction with the clients' medical team and clinical team.
  • Act as main responsible person at PLG for clients' concerns and escalation.
  • Medical review of the ICSRs (e.g., Spontaneous, literature).
  • Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.
  • Mentor junior medical reviewers and perform additional review of cases to ensure competency.
  • Provide feedback and ongoing workshops to develop the medical reviewers.
  • Participate in audits and inspections as required.
  • Ensure understanding of client needs, conventions and ensure expectations are met and exceeded.
  • Training and mentoring other team members.
Required Skills and Qualifications
  • Experience in leading medical review teams.
  • Client communications.
  • Safety Database experience.
  • 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.
Benefits
  • Opportunity to work with experienced professionals.
  • Chance to develop and enhance your skills.
  • Competitive compensation package.

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