Director, Medical Safety

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ulliConduct medical review of clinical trial and post-marketing safety data, including adverse events (AEs), adverse drug reactions (ADRs), coding, causality, expectedness, seriousness assessments, and benefit-risk evaluations. /liliProvide medical oversight and review of safety documentation, including narratives, aggregate reports, annual and periodic safety reports, risk management plans, regulatory submissions, labeling, protocols, investigator brochures, and case report forms. /liliSupport safety governance activities, including Data Safety Monitoring Boards, Safety Monitoring Committees, medical information escalations, pharmacovigilance oversight, and 24-hour medical support as required. /liliServe as Global Safety Physician, project lead, or medical safety advisor, ensuring quality, compliance, operational delivery, training, stakeholder communication, and timely completion of deliverables. /liliPresent safety findings and provide expert medical consultation to clients, internal teams, and cross-functional stakeholders. /liliLead and develop medical safety teams through people management, workload planning, performance management, mentoring, training, resource allocation, and succession planning. /liliOversee financial, operational, and quality performance of assigned projects, ensuring appropriate resourcing and regulatory compliance. /liliContribute to business development activities, including proposals, budgeting, bid defenses, client presentations, strategic planning, and service-line growth initiatives. /liliRepresent the Medical Safety function internally and externally, maintaining key stakeholder relationships and supporting organizational objectives. /liliDrive continuous improvement through awareness of industry, regulatory, and pharmacovigilance developments, and undertake special projects as required. /liliProvide global medical safety and pharmacovigilance oversight across clinical development and post-marketing programs. /liliLead medical review of safety data, regulatory reports, risk management strategies, and agevolazioni-risk assessments. /liliManage medical safety projects, ensuring quality, compliance, stakeholder engagement, and on-time delivery. /liliLead, develop, and resource teams of physicians and medical safety professionals globally. /liliSupport business growth through client engagement, proposals, strategic initiatives, and service-line leadership.



/li /ul h3Responsibilities /h3 ulliConduct medical review of clinical trial and post-marketing safety data, including adverse events (AEs), adverse drug reactions (ADRs), coding, causality, expectedness, seriousness assessments, and benefit-risk evaluations. /liliProvide medical oversight and review of safety documentation, including narratives, aggregate reports, annual and periodic safety reports, risk management plans, regulatory submissions, labeling, protocols, investigator brochures, and case report forms. /liliSupport safety governance activities, including Data Safety Monitoring Boards, Safety Monitoring Committees, medical information escalations, pharmacovigilance oversight, and 24-hour medical support as required. /liliServe as Global Safety Physician, project lead, or medical safety advisor, ensuring quality, compliance, operational delivery, training, stakeholder communication, and timely completion of deliverables. /liliPresent safety findings and provide expert medical consultation to clients, internal teams, and cross-functional stakeholders. /liliLead and develop medical safety teams through people management, workload planning, performance management, mentoring, training, resource allocation, and succession planning. /liliOversee financial, operational, and quality performance of assigned projects, ensuring appropriate resourcing and regulatory compliance. /liliContribute to business development activities, including proposals, budgeting, bid defenses, client presentations, strategic planning, and service-line growth initiatives. /liliRepresent the Medical Safety function internally and externally, maintaining key stakeholder relationships and supporting organizational objectives. /liliDrive continuous improvement through awareness of industry, regulatory, and pharmacovigilance developments, and undertake special projects as required. /liliProvide global medical safety and pharmacovigilance oversight across clinical development and post-marketing programs. /liliLead medical review of safety data, regulatory reports, risk management strategies,



and benefit-risk assessments. /liliManage medical safety projects, ensuring quality, compliance, stakeholder engagement, and on-time delivery. /liliLead, develop, and resource teams of physicians and medical safety professionals globally. /liliSupport business growth through client engagement, proposals, strategic initiatives, and service-line leadership. /li /ul h3Required Knowledge, Skills Experience /h3 ulliStrong knowledge of global pharmacovigilance, clinical research, safety reporting, Good Clinical Practice (GCP), and applicable regulatory requirements. /liliIn-depth understanding of clinical development, pharmaceutical research, and medical safety/monitoring activities. /liliProven ability to manage multiple priorities, meet deadlines, and deliver high-quality outcomes in a complex environment. /liliStrong consulting, communication, stakeholder management, and relationship-building skills, with the ability to influence clients and cross-functional teams. /liliDemonstrated leadership capability, including people management, project oversight, financial accountability, and strategic decision-making. /liliMedical degree (MD or equivalent) from an accredited institution, with substantial clinical practice experience and/or pharmaceutical physician experience. /li liSignificant experience in medical safety, pharmacovigilance, or medical monitoring within the pharmaceutical, biotechnology, CRO, or healthcare industry. /li liCurrent medical licensure (or equivalent professional registration) in the country of practice. /li /ul pIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at /p pIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8h1zl0