VAF 175 Medical Writing Specialist

Job Description

We are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety. Responsibilities: 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): Lead the medical reviewers Medical review of the ICSRs (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: MBBS, or MD (Doctor of Medicine) 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