Senior Medical Safety Expert
2 weeks ago
Position: Medical Safety Scientist
Work Arrangement: Fully Remote
Contract Duration: Long-term engagement with potential for extension
Essential Qualifications and Experience:
- At least 8 years of expertise in pharmacovigilance, including a minimum of 5 years focused on risk assessment and management.
- Proficient in independently navigating clinical safety and medical literature databases.
- Comprehensive understanding of pharmacovigilance guidelines, safety documentation, and risk evaluation.
- Exceptional medical writing capabilities and a track record of leading multidisciplinary teams.
- Thorough knowledge of medical and pharmaceutical terminology, alongside the clinical development lifecycle.
- Experience with MedDRA and safety data systems; adept with Windows software and quick to adapt to new applications/databases.
Educational Background:
- A degree (BS, BA, MSc, or PhD) or equivalent professional qualification in a life sciences discipline (e.g., nursing or pharmacy) or a related scientific/technical field.
Primary Responsibilities:
- Guide and support junior Medical Safety Scientists.
- Develop safety strategies and lead cross-functional Safety Management Teams.
- Manage signal detection and safety reporting workflows.
- Ensure adherence to regulatory standards and readiness for inspections.
- Contribute to international regulatory submissions and risk management strategies.
- Provide insights on medical safety for clinical development and safety agreements.
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