Senior Regulatory Affairs Specialist

1 week ago

Ajmer, Rajasthan, India beBeePharmacovigilance Full time ₹ 1,20,00,000 - ₹ 2,00,00,000

Job Overview

This position offers a unique opportunity to lead and manage medical review teams, ensuring compliance with regulatory requirements. As a Senior Medical Advisor, you will be responsible for reviewing study protocols, drafting medical monitoring plans, and interpreting clinical data.

Key Responsibilities

  • Lead as a medical monitor/Medical expert in clinical phase
  • Review and provide feedback on study protocols as needed
  • Deliver therapeutic area training for all case processing team
  • Drafting medical monitoring plans (MMP) and ensuring compliance
  • Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions
  • Make assessments on SUSAR reportability
  • Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for clients
  • 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 an 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

Requirements

  • 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

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
  • Working knowledge of EDC systems
  • Good Medical knowledge and Pharmacology understanding

Education

  • MBBS, or MD (Doctor of Medicine)

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