Senior Clinical Pharmacovigilance Advisor

2 days ago

Mysore, Karnataka, India beBeeClinical Full time ₹ 40,00,000 - ₹ 50,00,000

Job Opportunity

We are seeking an experienced medical professional to lead our clinical and pharmacovigilance team. The successful candidate will have extensive experience in leading medical review teams, client communications, and safety database management.

Clinical Phase Responsibilities:

  • Medical Oversight: Lead as a medical monitor/Medical expert and ensure effective communication with clients, attend investigator meetings as required, and provide support to sites regarding protocol or possible drug interactions.
  • Protocol Review: Review and provide feedback on study protocols as needed.
  • T therapeutic Area Training: Deliver therapeutic area training for all case processing team members.
  • Medical Monitoring Plans: Draft medical monitoring plans (MMP) and ensure compliance.
  • Adverse Event Review: Review adverse events reported by study sites, assessing their severity, and determining appropriate actions.
  • SUSAR Reportability: Make assessments on SUSAR reportability.
  • Monthly Reports: 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) Responsibilities:

  • Platform Support: Support maintenance of medical platform including SOPs, manual, and documents.
  • Medical Review: Lead and support the medical reviewers, interaction with the clients' medical team and clinical team, act as main responsible person for clients concerns and escalation.
  • ICSR Review: Medical review of ICSRs (e.g., Spontaneous, literature).
  • Causality Assessment: Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.
  • Training and Mentoring: Mentor junior medical reviewers and perform additional review of cases to ensure competency, provide feedback, and ongoing workshops to develop the medical reviewers.

Requirements:

  • Doctor of Medicine degree (MBBS or MD)
  • Experience in leading medical review teams, client communications, safety database experience, minimum 10 years of experience working for service providers or pharmaceutical companies, and at least 5-7 years of experience as a Medical Monitor or clinical phase.
  • 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 and good medical knowledge and pharmacology understanding.

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