Global Medical Safety Director
1 week ago
As a Global Medical Safety Lead at Pharmiweb, you will be part of a world-class clinical research organization, leveraging healthcare intelligence to drive innovation. Your key responsibilities will include:
Key Responsibilities- Providing strategic medical safety leadership and practical contributions for assigned products in a cross-functional setting
- Performing safety signal management and benefit-risk assessment activities, as well as regular and ad-hoc aggregate safety data reviews for assigned products
- Leading cross-functional teams to perform regular and ad-hoc reviews of existing and emerging aggregate safety data for assigned products
- Contributing to the development of the overall safety governance structure and activities
- Providing safety strategies and delivering accurate, timely, and high-quality safety contributions for regulatory submission documents globally
- Preparing and reviewing safety sections of clinical and regulatory documents, including study protocols, IBs, Clinical Study Reports, and ICFs
- Providing medical safety support for responses to regulatory authority inquiries, ensuring timely, complete, and accurate safety information
- Leading the preparation of periodic safety reports, including PSURs and DSURs, and ensuring medical safety content and consistency
- Overseeing medical assessments of individual case safety reports (ICSR)
- Confirming criteria and content for expedited reporting and unblinding, including SUSARs and urgent safety issues
- Leading or contributing to the preparation and presentation of safety information to the Data Safety Monitoring Board (DSMB)
- Providing medical safety contributions at internal audits and regulatory inspections
- Supporting the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents
- Supporting adverse event reporting training and pharmacovigilance awareness activities cross-functionally
- Supporting the preparation of pharmacovigilance agreements with clinical development or commercial business partners
- Participating in cross-functional teams and initiatives
- MD degree or equivalent required
- At least 7 years of relevant experience in the pharmaceutical/biotech industry, with at least 5 years in pharmacovigilance/drug safety (global experience a plus)
- At least 1 year of experience in clinical practice or academic medicine
- Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents
- Demonstrated ability to perform medical assessments of safety data from multiple sources
- Experience with authoring complex documents and contributing to regulatory submissions
- Knowledge of adverse event reporting systems
- Experience in epidemiology, biostatistics, clinical development, or medical affairs a plus
- Strong scientific and analytic skills
- Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment
- Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams
- Excellent presentation skills with the ability to communicate complex issues clearly
- Relevant computer skills, including proficiency with Microsoft Office
At Pharmiweb, we value diversity, inclusion, and belonging. Our rich diversity makes us more innovative, helping us better serve our people, patients, customers, and communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through this form.
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