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Senior Medical Safety Lead

2 weeks ago

Guntur, Andhra Pradesh, India beBeeMedical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Medical Expert Lead

We are seeking a seasoned Medical Advisor to lead our medical review teams. As a key member of our team, you will be responsible for ensuring the highest standards of medical excellence in all aspects of clinical and post-marketing drug safety.

Clinical Phase
  • Lead as a medical monitor/Medical expert, overseeing clinical trials and ensuring compliance with regulatory requirements.
  • With extensive experience in medical monitoring, you will 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, ensuring the accuracy and integrity of our research.
  • Deliver therapeutic area training for all case processing team members, promoting knowledge sharing and expertise.
  • 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, maintaining high standards of quality control.
  • Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions, such as dose adjustments or trial discontinuation.
  • Make assessments on SUSAR reportability, ensuring timely and accurate reporting.
  • Perform the review and interpret clinical data, ensure protocol compliance, and draft monthly reports for clients, with presentation at periodic meetings if required.
Post-Marketing (Pharmacovigilance)
  • Support in maintenance of medical platform including SOPs, manual, and documents.
  • Lead and support the medical reviewers, mentoring junior team members and providing ongoing feedback.
  • Interaction with the clients medical team and clinical team, ensuring seamless communication and collaboration.
  • Act as main responsible person at PLG for clients concerns and escalation, resolving issues promptly and professionally.
  • Medical review of ICSRs (e.g., Spontaneous, literature), supporting the identification and assessment of potential safety risks.
  • Support in causality, medical assessment, benefit-risk evaluation of the medicinal product, ensuring thorough and accurate analysis.
  • Mentor junior medical reviewers and perform additional review of cases to ensure competency, promoting professional growth and development.
  • Provide feedback and ongoing workshops to develop the medical reviewers, fostering a culture of continuous learning.
  • Participate in audits and inspections as required, ensuring compliance with regulatory requirements and industry best practices.
  • Ensure understanding of client needs, conventions, and expectations, meeting and exceeding client expectations.
  • Training and mentoring other team members, promoting knowledge sharing and expertise within the organization.

Required education: MBBS, or MD (Doctor of Medicine).

Required skills:

  • Leadership experience in medical review teams, with a minimum of 10 years working for service providers or pharmaceutical companies.
  • Effective client communication, with a strong focus on relationship building and maintenance.
  • Safety Database expertise, with a deep understanding of pharmacovigilance principles and practices.
  • Minimum 5-7 years of experience as a Medical Monitor or clinical phase, with a proven track record of success.

Required technical skills:

  • Microsoft package, with proficiency in relevant software applications.
  • 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.
  • Working knowledge of EDC systems, with the ability to navigate complex data sets.
  • Good Medical knowledge and Pharmacology understanding, with a solid foundation in clinical research methodology.