What are the responsibilities and job description for the Associate Director, Pharmacovigilance position at GQR?
The Associate Director of Pharmacovigilance will provide expert PV leadership to independently review and assess safety information from various sources. This includes evaluating medical content and leading the identification of potential safety signals at both the individual case and aggregate levels. The role involves taking the lead in safety activities and benefit-risk assessments for assigned programs, chairing Safety Surveillance Committees, and contributing significantly to Independent Data and Safety Monitoring Committees (DSMCs) meetings.
Qualifications :
- MD or equivalent required.
- Postgraduate qualification or experience in gene therapy, cell therapy clinical development, or a related specialty is preferred.
- At least 8 years of experience in pharmacovigilance.
- In-depth knowledge of pharmacovigilance processes and the ability to apply this expertise to evaluate safety concerns and minimize patient risk throughout the product lifecycle.
- Experience in the cardiovascular or rare disease is highly desirable.
Responsibilities :
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