Medical Director, Drug Safety

Title: Medical Director, Drug Safety

Location: Remote

Job Type: Long Term Contract

Job Description:

•  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.

Required Skills:

• 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.

Education:

MD, or MD PhD, or MD MPH required; sub specialty training highly desirable