Patient Safety Director
5 days ago
Introduction
We are currently hiring a Patient Safety Director for our client, a global pharmaceutical company known for its innovative technology and products in nutrition, diagnostics, medical devices, and branded generic pharmaceuticals.
This role involves leading the clinical safety strategy for assigned drug projects and products across all stages of development and post-marketing. The focus is on ensuring the ongoing assessment, evaluation, and risk management of the products to maintain safety profiles.
Responsibilities
Develop and implement clinical safety strategies, including risk identification, mitigation, and benefit-risk assessment.
Review and endorse risk management plans and safety specifications.
Provide strategic safety input for clinical development and regulatory submissions.
Collaborate with cross-functional teams to ensure safety measures are integrated into key project documents.
Represent patient safety in meetings and provide medical input for safety-related issues.
Conduct safety surveillance, signal detection, and risk evaluations.
Provide medical expertise for safety data assessments and regulatory documentation for label updates.
Collaborate on signal management and communicate findings to relevant stakeholders.
Contribute to periodic safety reports and regulatory submissions for new products or indications.
Support safety agreements, licensing discussions, and internal/external regulatory meetings.
Contribute to process improvements, methodology advancements, and team training.
Address concerns and maintain readiness for audits or inspections.
Requirements
Medical degree (e.g., MD, MBBS)
at least 5 years of experience with clinical drug safety and pharmacovigilance; including safety strategy for drug products in clinical development within the pharmaceutical industry.
Experience across therapeutic areas and functions, including team supervision
Familiarity with epidemiological data analysis.
What We Offer
Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We will get you going while you get on with the job.
About Us
Brunel has a reputation for working with some of the best in the business. That is what we continually strive for. Over 45 years, we have created a global network of interesting clients and talented individuals working together through a vast array of services.
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