Global Clinical Safety Strategist
1 day ago
Job Summary
We are seeking a highly skilled Global Clinical Safety Strategist to join our team at Brunel, a leading recruitment agency with a global network of clients and talented professionals.
The successful candidate will be responsible for leading the clinical safety strategy for assigned drug projects and products across all stages of development and post-marketing. This role involves ensuring the ongoing assessment, evaluation, and risk management of the products to maintain safety profiles.
About the Role
Key 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
To be successful in this role, you will need:
- A medical degree (e.g., MD, MBBS).
- No less than 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.
About Us
Brunel has a reputation for working with some of the best in the business. Over 45 years, we have created a global network of interesting clients and talented individuals working together through a vast array of services. We offer an attractive salary package and excellent benefits to our employees. The estimated annual salary for this position is approximately $120,000 - $180,000 depending on location and experience.
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