Director, Medical Safety- Sponsor-Dedicated

Conduct 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. Provide 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.

Support safety governance activities, including Data Safety Monitoring Boards, Safety Monitoring Committees, medical information escalations, pharmacovigilance oversight, and 24-hour medical support as required. Serve as Global Safety Physician, project lead, or medical safety advisor, ensuring quality, compliance, operational delivery, training, stakeholder communication, and timely completion of deliverables. Present safety findings and provide expert medical consultation to clients, internal teams, and cross-functional stakeholders.

Lead and develop medical safety teams through people management, workload planning, performance management, mentoring, training, resource allocation, and succession planning. Oversee financial, operational, and quality performance of assigned projects, ensuring appropriate resourcing and regulatory compliance. Contribute to business development activities, including proposals, budgeting, bid defenses, client presentations, strategic planning, and service-line growth initiatives.

Represent the Medical Safety function internally and externally, maintaining key stakeholder relationships and supporting organizational objectives. Drive continuous improvement through awareness of industry, regulatory, and pharmacovigilance developments, and undertake special projects as required. Provide global medical safety and pharmacovigilance oversight across clinical development and post-marketing programs. Lead medical review of safety data, regulatory reports, risk management strategies, and benefit-risk assessments.

Manage medical safety projects, ensuring quality, compliance, stakeholder engagement, and on-time delivery. Lead, develop, and resource teams of physicians and medical safety professionals globally. Support business growth through client engagement, proposals, strategic initiatives, and service-line leadership.

Responsibilities

Conduct 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. Provide 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.

Support safety governance activities, including Data Safety Monitoring Boards, Safety Monitoring Committees, medical information escalations, pharmacovigilance oversight, and 24-hour medical support as required. Serve as Global Safety Physician, project lead, or medical safety advisor, ensuring quality, compliance, operational delivery, training, stakeholder communication, and timely completion of deliverables. Present safety findings and provide expert medical consultation to clients, internal teams, and cross-functional stakeholders.

Lead and develop medical safety teams through people management, workload planning, performance management, mentoring, training, resource allocation, and succession planning. Oversee financial, operational, and quality performance of assigned projects, ensuring appropriate resourcing and regulatory compliance. Contribute to business development activities, including proposals, budgeting, bid defenses, client presentations, strategic planning, and service-line growth initiatives.

Represent the Medical Safety function internally and externally, maintaining key stakeholder relationships and supporting organizational objectives. Drive continuous improvement through awareness of industry, regulatory, and pharmacovigilance developments, and undertake special projects as required. Provide global medical safety and pharmacovigilance oversight across clinical development and post-marketing programs. Lead medical review of safety data, regulatory reports, risk management strategies, and benefit-risk assessments.

Manage medical safety projects, ensuring quality, compliance, stakeholder engagement, and on-time delivery. Lead, develop, and resource teams of physicians and medical safety professionals globally. Support business growth through client engagement, proposals, strategic initiatives, and service-line leadership.

Required

Knowledge, Skills & Experience

Strong knowledge of global pharmacovigilance, clinical research, safety reporting, Good Clinical Practice (GCP), and applicab