- Location
- Zagreb, Croatia · Belgrade, Serbia · Lisbon, Portugal · Budapest, Hungary · Athens, Greece · Barcelona, Spain · Prague, Czech Republic · Madrid, Spain
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Director
- Education
- PhD
- Source
- Workday
Description
Position Summary
The Medical Safety Director, Clinical Scientist provides clinical science support to product activities, ensuring high-quality clinical input into routine maintenance documentation, safety and labeling deliverables, and issue resolution activities.
This role partners closely with cross-functional product teams, represents Clinical Science in key governance forums, and provides expert clinical review and recommendations to support product benefit-risk evaluation, regulatory compliance, and labeling consistency. The position works in close collaboration with the Global Clinical Science Lead, escalating critical issues and contributing to timely, scientifically robust decision-making.
Key responsibilities
Participate in relevant product-team meetings including Labelling Working Group (LWG)as the Clinical Science representative
Gather and provide necessary information under guidance from the GCL
Review draft documents (PBRER/PSUR, CCDS/CCSI, US Annual Report) from a Clinical Science perspective; share key points and any critical issues with the GCL
Participate in relevant Safety Management Team (SMT) meetings as the Clinical Science representative
Review Safety Validation and Evaluation Report draft documents; share key points and any critical issues with the GCL etc.
Required Experience
MD, PharmD, PhD, or equivalent advanced life sciences degree with strong clinical science expertise and the ability to interpret clinical, safety, and scientific literature within a benefit-risk framework.
Proven experience supporting regulatory and pharmacovigilance deliverables, including PBRER/PSUR, CCDS/CCSI, US Annual Reports, and Safety Evaluation Reports.
Hands-on experience reviewing and contributing to clinical sections of safety, regulatory, and labeling documents, ensuring scientific accuracy, consistency, and compliance.
Strong knowledge of drug safety, pharmacovigilance, risk management, and global labeling processes within the pharmaceutical industry.
Experience participating in cross-functional product teams, Safety Management Teams (SMTs), and Labeling Working Groups (LWGs) as a Clinical Science representative.
Demonstrated ability to evaluate clinical and safety data, identify risks, resolve issues, and provide clear, actionable recommendations and document wording.
Experience supporting CCDS updates, emerging safety topics, issue resolution activities, and responses to regulatory or local market queries.
Excellent scientific communication, stakeholder management, and collaboration skills within a global matrix environment.
Strong attention to detail, quality mindset, and ability to manage multiple priorities while delivering high-quality outputs within tight timelines.
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.
