Senior Clinical Safety Specialist

Seeking an experienced Medical Advisor to lead our clinical and post-marketing drug safety initiatives. Clinical Phase: Lead as a medical monitor, utilizing expertise in all aspects of clinical drug safety. Experience in medical monitoring is essential, with the ability to effectively communicate with clients, attend investigator meetings, and provide support to sites regarding protocol or possible drug interactions. Review and provide feedback on study protocols as needed. Develop and deliver therapeutic area training for all case processing team members. May require 24/7 availability depending on client needs for possible queries or protocol deviations resulting in potential harm to patients. Drafting medical monitoring plans (MMP) and ensuring compliance. Review adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions. Assess reportability of SUSARs. Perform review and interpretation of clinical data, ensure protocol compliance, and draft monthly reports for clients (with presentations 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 maintenance of medical platform including SOPs, manual, and documents. Lead and support medical reviewers. Interact with client medical teams and clinical teams. Act as main responsible person at PLG for client concerns and escalation. Medical review of ICSRs (e.g., Spontaneous, literature). Support causality, medical assessment, benefit-risk evaluation of medicinal products. Mentor junior medical reviewers and perform additional review of cases to ensure competency. Provide feedback and ongoing workshops to develop medical reviewers. Participate in audits and inspections as required. Ensure understanding of client needs, conventions, and meet expectations. Train and mentor other team members. Requirements: MBBS or MD (Doctor of Medicine) Experience leading medical review teams. Client communications skills. Safety Database experience. Minimum 10 years experience working for service providers or pharmaceutical companies. At least 5-7 years of experience as a Medical Monitor or clinical phase. Required 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, and causality assessment. Working knowledge of EDC systems. Good medical knowledge and pharmacology understanding.

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