Director, Medical Safety
IQVIA · Zagreb +8 · 21d ago
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.