Oversees, prepares and reviews scheduled periodic/annual reports (FDA) and Periodic Safety Update Reports (FDA and Global FDA).
Contributes in INDs, IMPDs and other regulatory submissions, and plays an important role in the required regulatory interactions with the FDA, EMEA and other regulatory authorities.
We are offering Competitive Compensation and Benefits.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Advanced degree in Medicine
3 years of drug safety/pharmacovigilance experience in a pre-approval setting
Experience in clinical safety, pharmacovigilance and risk management within the pharmaceutical industry is required (5 years experience for Director, 7 years for Senior Director, 10 years for Executive Director)
Experience in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.