Description
We are seeking an Associate Medical Safety Director to join our Lifecycle Safety Medical team. The successful candidate will participate in all aspects of Medical Safety activities, providing and maintaining PV and risk management expertise to internal and external stakeholders.
Responsibilities:
- Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile
- Lead signal detection and analysis, including signal detection strategy, frequency, and timing
- Review and contribute to signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up
- Prepare and/or contribute to responses to questions from health authorities
- Review and contribute to periodic aggregate reports
- Contribute to safety review of study protocols, investigators brochure and other reference safety information
- Serve as an internal consultant for any medical support for pharmacovigilance operations
Requirements:
- A medical degree from an accredited and internationally recognized medical school
- Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research
- Experience in Signal detection, Aggregate reports and Risk management
- Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing
The potential base pay range for this role, when annualized, is €53,000.00 - €90,200.00.