Director, Medical Safety- Sponsor-Dedicated (m/w/d)

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

Job summary

IQVIA Inc. seeks a Global Safety Physician to lead medical safety activities across development and post-marketing programs. You will oversee safety data reviews, regulatory submissions, and risk management strategies, while mentoring a global team of physicians and safety professionals.

You will contribute to proposals, budgeting, and client presentations, ensuring high-quality deliverables and regulatory compliance. This is a senior, influential role within a leading life sciences organization.

Qualifications

• Strong knowledge of global pharmacovigilance, clinical research, safety reporting, Good Clinical Practice (GCP), and 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 or pharmaceutical physician experience.
• Significant experience in medical safety, pharmacovigilance, or medical monitoring within pharma/biotech/CRO/healthcare.
• Current medical licensure in the country of practice.

Responsibilities

• Conduct medical review of clinical trial and post-marketing safety data, including AEs/ADRs, coding, causality, expectedness, seriousness, and benefit-risk assessments.
• Provide medical oversight and review of safety documentation (narratives, reports, safety plans, regulatory submissions, labeling, IBs, CRFs).
• Support safety governance activities, including DSMBs, Safety Monitoring Committees, medical information escalations, and 24-hour medical support.
• Serve as Global Safety Physician, project lead, or medical safety advisor to ensure quality, compliance, and timely delivery.
• Present safety findings and provide expert medical consultation to clients and cross-functional teams.
• Lead and develop medical safety teams with workload planning, performance management, mentoring, and resource allocation.
• Oversee financial, operational, and quality performance of projects, ensuring appropriate resourcing and regulatory compliance.
• Contribute to business development via proposals, budgeting, client presentations, and service-line growth.
• Represent the Medical Safety function internally and externally, maintaining stakeholder relationships and supporting objectives.
• Drive continuous improvement through industry/regulatory developments and pharmacovigilance trends.
• Provide global medical safety oversight across development and post-marketing programs.
• Lead medical review of safety data, regulatory reports, risk management strategies, and benefit-risk assessments.
• Manage medical safety projects with quality and on-time delivery.
• Lead, develop, and resource teams of physicians and medical safety professionals globally.
• Support business growth through client engagement and strategic initiatives.

Skills

Global pharmacovigilance

Clinical research

GCP

Regulatory knowledge

Leadership

Stakeholder management

Communication

Project oversight

Financial accountability

Education

MD or equivalent

Job description

Frankfurt, Hesse, Germany

Budapest, Hungary

Sofia, Bulgaria

Ljubljana – Dunajska, Slovenia

Bucuresti, Romania

Madrid, Spain

Lisbon, Portugal

Zaventem, Belgium

Belgrade, Serbia

Riga, Latvia

Zagreb, Croatia

Reading, Berkshire, United Kingdom

Prague, Czech Republic

Tallinn, Estonia

Copenhagen, Denmark

Full time

R1558654

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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