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 applicable regulatory requirements.
- In-depth understandi