Director, Medical Safety- Sponsor-Dedicated (Home-based)

IQVIA; Wien; On-site; EUR 120,000 - 180,000; Full time

Job summary

IQVIA seeks a Global Safety Physician to lead medical safety across clinical development and post-marketing programs. You will provide medical oversight, ensure regulatory compliance, and partner with clients and internal teams to deliver high-quality safety deliverables.

This role requires an MD or equivalent, extensive pharmacovigilance experience, and strong leadership to mentor safety professionals and drive strategic initiatives within a global matrix.

Qualifications

• Strong knowledge of global pharmacovigilance, clinical research, safety reporting, GCP, and regulatory requirements.
• Deep understanding of clinical development and medical safety/monitoring activities.
• Proven ability to manage multiple priorities, meet deadlines, and deliver high-quality outcomes.
• Strong consulting, communication, stakeholder management, and relationship-building skills.
• Demonstrated leadership including people management, project oversight, and strategic decision-making.
• Medical degree (MD or equivalent) with substantial clinical practice and/or pharmaceutical physician experience.
• Significant experience in medical safety, pharmacovigilance, or medical monitoring in pharma/biotech/CRO.
• Current medical licensure (or equivalent) in the country of practice.

Responsibilities

• Conduct medical review of safety data across clinical and post-marketing activities.
• Provide medical oversight of safety documentation and regulatory submissions.
• Support safety governance, DSMBs, MSPs, and 24-hour medical support.
• Serve as Global Safety Physician, project lead, and medical safety advisor.
• Present safety findings and provide expert consultation to clients and teams.
• Lead medical safety teams with mentoring, workload planning, and succession.
• Oversee financial, operational, and quality performance of projects.
• Contribute to business development through proposals and client presentations.
• Represent Medical Safety and maintain stakeholder relationships.
• Drive continuous improvement with industry/regulatory developments.

Skills

Pharmacovigilance

Clinical development

Regulatory compliance

Leadership

Stakeholder management

Medical governance

Education

MD or equivalent

Job description

• 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 understanding of clinical development, pharmaceutical research, and medical safety/monitoring activities.
• Proven ability to manage multiple priorities, meet deadlines, and deliver high-quality outcomes in a complex environment.
• Strong consulting, communication, stakeholder management, and relationship-building skills, with the ability to influence clients and cross-functional teams.
• Demonstrated leadership capability, including people management, project oversight, financial accountability, and strategic decision-making.
• Medical degree (MD or equivalent) from an accredited institution, with substantial clinical practice experience and/or pharmaceutical physician experience.
• Significant experience in medical safety, pharmacovigilance, or medical monitoring within the pharmaceutical, biotechnology, CRO, or healthcare industry.
• Current medical licensure (or equivalent professional registration) in the country of practice.

IQVIA 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 https://jobs.iqvia.com

IQVIA 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.