Medical Advisor (Pharmacovigilance)

proficient in all aspects of clinical and post-marketing drug safety

Clinical Phase:

• Lead as a medical monitor/Medical expert
• Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as required and provide support to sites regarding protocol or possible drug interactions is essential.
• Review and provide feedback on study protocols as needed.
• Deliver therapeutic area training for all case processing team.
• May require 24/7 availability depending on the 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 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

Required education

Required experience :

• 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

Required 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