Medical Director, Drug Safety
Title: Medical Director, Drug Safety
Job Type: Long Term Contract
- Responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
- Manage safety surveillance for assigned compounds / products.
- Manage collection, in cooperation with a PV scientist, of current data for safety signalling and identify and investigate safety signals.
- Conduct analysis of safety data.
- Provide safety strategic leadership for clinical development programs / program teams.
- Integrate the safety scientific component to build a strategic framework for clinical development plans.
- Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.
- Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.
- Minimum 7 years’ experience in the pharmaceutical industry or clinical care setting.
- Preferably has prior experience in pharmacovigilance or clinical development.
- Knowledge of pre- and post- marketing US and EU regulations
- Knowledge of clinical epidemiology/biostatistics or clinical pharmacology highly desirable.
- Excellent communication skills (oral and written) and excellent organizational skills.
MD, or MD PhD, or MD MPH required; sub specialty training highly desirable