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Global Medical Safety Director
hace 2 semanas
Get AI-powered advice on this job and more exclusive features. Job Title: Global Medical Safety Director Location: Fully Home-Based (UK/EU) – Travel ~1x per month within EU Contract Type: 12-Month Fixed Term Company Overview This is a unique opportunity to work with a leading global pharmaceutical company through a well-established CRO renowned for delivering high-quality, patient-focused clinical research. Working in this outsourced FSP role, you will contribute directly to the sponsor’s clinical programs while benefiting from the CRO’s supportive, collaborative, and flexible environment. You’ll have the chance to make a tangible impact on global medical safety operations, all while enjoying the flexibility of a fully home-based position with minimal travel. Role Overview As the Global Medical Safety Director, you will oversee all aspects of medical safety within the clinical development portfolio, beyond routine case processing. You will provide strategic and operational leadership across pharmacovigilance and safety-related activities, ensuring compliance with global regulatory requirements and contributing to the development of safety strategies. This is a director-level role offering a unique opportunity to shape global safety operations in a flexible, remote environment. Key Responsibilities Oversee pharmacovigilance activities across clinical development, including safety strategy, risk management, and regulatory compliance. Collaborate with cross-functional teams to support registration dossiers and submissions. Guide safety-related aspects of clinical trial planning, conduct, and reporting beyond routine case management. Ensure alignment with corporate and regulatory standards for medical safety globally. Perform medical review of pre- and post-marketing Individual Case Safety Reports (ICSRs) , ensuring accurate MedDRA coding and appropriate assessments (seriousness, expectedness, causality). Support the follow-up of high-priority IC RSs to ensure complete and accurate safety data. Collaborate with Clinical Science, Medical Affairs, and Pharmacovigilance colleagues to identify and evaluate safety signals . Contribute to the creation and maintenance of safety surveillance and risk management plans . Prepare aggregate safety reports (e.g., 15‑day Alert Reports, SUSARs, PSURs, US PADERs, DSURs, IND Annual Reports). Participate in Safety Management Team meetings and liaise with study teams, CROs, and regulatory partners. Support the preparation and review of clinical and regulatory safety documents , including protocols, CSRs, IBs, and submission materials. Interface with business partners in line with applicable Safety Data Exchange Agreements (SDEAs) . Candidate Requirements MD background. 10–15 years of experience in pharmacovigilance, medical safety, or related clinical development roles. Strong experience across PVG aspects of clinical development (not limited to case processing). Prior experience as a clinical trial physician or in medical monitoring is advantageous. Experience with regulatory submissions and registration dossiers is a plus. Previous pharmaceutical industry experience preferred. Director-level experience with proven ability to lead and influence cross-functional teams. No specific therapeutic area expertise required. Excellent communication skills in English; ability to work independently and within a remote team. Willingness to travel once per month within the EU. What’s on Offer Competitive contract rate. Fully home-based, flexible working. Opportunity to lead global medical safety strategy at a director level. Exposure to international regulatory and clinical development operations. Work on high-impact, patient-focused programs while benefiting from a collaborative CRO environment. Referrals increase your chances of interviewing at i-Pharm Consulting by 2x. #J-18808-Ljbffr
