Future Opportunities - Join Our Talent Pipeline for Medical Directors- Patient Safety
About The Position
Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise. In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our talent pipeline and considered for future opportunities. Medical Directors within the Patient Safety, Epidemiology and Quality team are responsible for the following:
Requirements
- MD / DO with 2+ years of residency with patient management experience
- 5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
- Effectively analyze and guide analysis of clinical data and epidemiological information
- Effectively present recommendations / opinions in group environment both internally and externally
- Write, review and provide input on technical documents
- Work collaboratively and lead cross-functional teams
Responsibilities
- Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
- Responsible for safety surveillance for pharmaceutical / biological / drug -device combined early oncology product and implementing risk management strategies for assigned product
- Lead, set the strategy in collaboration with the development medical lead of study protocols and informed consents. When appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, aggregate reports.
- Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents. Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management
- Independently write, review, and provide input on technical documents. Oversight and responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports (e.g. DSUR's, PADER's and Safety sections of the IBs)
- Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k) to eligible employees
- short-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
