BioCryst Pharmaceuticals, Inc.
The Sr. Medical Director, Global Drug Safety & PV is responsible for pharmacovigilance and drug safety activities across Phase I - IV clinical studies, drug product development, and postmarketing settings. This role involves ongoing safety surveillance, signal detection and management, medical case review, and providing safety assessment expertise to clinical and regulatory teams.
Key Responsibilities
- • Accountable for pharmacovigilance and drug safety activities for assigned Phase I - IV clinical studies, drug product development, and in postmarketing settings
- • May be consulted or have responsibilities for safety aspects of Phase IV studies conducted by medical affairs if appropriate
- • Responsible for ongoing safety surveillance
- • Responsible for signal detection and management
- • Medical review of cases
- • Providing pharmacovigilance and safety assessment expertise to clinical and regulatory teams
Company Overview
Industry: Healthcare Technology
Company Size: 500-1,000 employees
Founded: 2015
Headquarters: San Francisco, CA
Company Links
Key Contacts
Contact information not available
About the Company
Leading healthcare technology company focused on improving patient outcomes through innovative digital solutions. We're transforming the way healthcare is delivered with cutting-edge technology and data-driven insights. Our platform serves over 10,000 healthcare professionals and has processed millions of patient interactions.
Recent News & Updates
At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.
The Sr. Medical Director, Global Drug Safety & PV will be accountable for pharmacovigilance and drug safety activities for assigned Phase I - IV clinical studies, drug product development, and in postmarking settings. In addition, the Medical Director may be consulted or have responsibilities for safety aspects of Phase IV studies conducted by medical affairs if appropriate. The Sr. Medical Director is responsible for ongoing safety surveillance, signal detection and management, medical review of cases, and providing pharmacovigilance and safety assessment expertise to clinical and regulatory teams.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Keep track of your job search
Save personal notes for each job to track your thoughts, application status, and follow-ups.
Try for freeUpload your resume
Sign up to upload your resume and get AI-powered customization for job applications.
Sign up freePractice your interview
Get AI-powered mock interviews tailored to this Sr Medical Director, Global Drug Safety & Pharmacovigilance role. Upload your resume and practice with real-time voice feedback.
Sign up to practice