Clinical Pharmacovigilance Expert

3 days ago

Allahabad, Uttar Pradesh, India beBeeRegulatory Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Medical Review Lead

As a seasoned medical review lead, you will oversee our team of medical reviewers in ensuring the highest standards of clinical and post-marketing drug safety.

Clinical Phase:
  • Lead as a medical monitor/Medical expert, responsible for effective communication with clients, attending investigator meetings, and providing support to sites regarding protocol or possible drug interactions.
  • Review and provide feedback on study protocols as needed, ensuring compliance with regulatory requirements.
  • Deliver therapeutic area training for all case processing team members, equipping them with the knowledge to make informed decisions.
  • Maintain 24/7 availability to address client queries or protocol deviations that may impact patient safety.
  • Draft medical monitoring plans (MMP) and ensure compliance with established guidelines.
  • Assess adverse events reported by study sites, determine appropriate actions, and make assessments on SUSAR reportability.
  • Perform reviews and interpretations of clinical data, ensuring protocol compliance and drafting monthly reports for clients.
Post-Marketing (Pharmacovigilance):
  • Support maintenance of medical platform including SOPs, manuals, and documents, ensuring seamless operations.
  • Lead and support medical reviewers in their daily tasks, fostering a collaborative environment.
  • Interact with clients' medical teams and clinical teams, providing guidance and expertise as needed.
  • Act as the primary point of contact at PLG for client concerns and escalations, ensuring timely resolutions.
  • Conduct medical reviews of ICSRs, assessing causality, medical assessment, benefit-risk evaluation, and supporting pharmacovigilance activities.
  • Mentor junior medical reviewers, perform additional reviews to ensure competency, and provide ongoing workshops to develop skills.
  • Participate in audits and inspections as required, upholding the highest standards of quality and compliance.

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

Required experience :

  • Experience in leading medical review teams, with a strong focus on client communications, safety database management, and regulatory compliance.
  • At least 10 years of experience working for service providers or pharmaceutical companies, with a minimum of 5-7 years in medical monitoring or clinical phase roles.

Required technical skills:

  • Microsoft package proficiency
  • Deep understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
  • Working knowledge of EDC systems, with a strong foundation in pharmacovigilance principles, adverse event reporting, and causality assessment.
  • Good medical knowledge and pharmacology understanding, with a strong analytical mindset.

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