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Safety Associate
Il y a 2 mois
Job Purpose: We are seeking a dedicated Safety Physician to actively manage and evaluate risks associated with assigned vaccine projects. The successful candidate will work closely with the Safety Scientist to coordinate medical analyses of adverse event reports and support signal detection activities.
Key Responsibilities:
- Conduct medical analysis of adverse event reports and signal detection for assigned vaccine projects in clinical development and post-licensure.
- Serve as the safety contact for Clinical, Regulatory Affairs, regional, and local safety managers.
- Provide medical input on safety aspects in the design and preparation of clinical protocols, investigator brochures, and reports.
- Conduct Benefit-Risk Assessments and manage risk identification, assessment, and mitigation for vaccine projects.
- Lead the Safety Review Team and participate as a member of the Vaccine Leadership Team (VLT) for assigned projects.
- Develop and revise pharmacovigilance processes and training materials.
- Respond to inquiries from regulatory authorities regarding safety aspects of the projects.
- Ensure compliance with applicable regulations and participate in safety-related interactions with external collaborators.
Required Profile:
- Medical Doctor with a preferred specialization in Infectious Diseases, Epidemiology, or Vaccines.
- Minimum 3 years of post-registration clinical experience and at least 2 years in Pharmacovigilance within the Pharmaceutical or Biotech industry.
- Strong knowledge of Pharmacovigilance tools, signal detection, and safety reporting for vaccines.
- In-depth understanding of the regulatory environment, including International, US, and European legislation.
- Excellent understanding of the vaccine development process and safety regulations.
- Proven ability to manage crises, monitor safety issues, and work effectively under pressure.
- Strong analytical skills with attention to detail and the ability to prioritize tasks.
- Excellent English communication skills (written and spoken); French is a plus but not mandatory.
- Computer literate and familiar with scientific and clinical databases.
Complexity:
- Ability to make independent clinical assessments and decisions in a complex, multinational study environment.
- Capacity to generate reliable evaluations and recommendations based on large datasets (200,000 subjects).
- Ability to provide scientifically-based safety assessments within a complex public environment.
What We Offer:
- Fully Remote Opportunity
