Medical Advisor

3 days ago

New Delhi, India ProductLife Group Full time

We are looking for a Team lead/ Manager/ senior medical advisor/reviewer 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 membersRequired 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 phaseRequired 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

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