Director, Safety Science & PV Vendor Oversight

COMPANY:

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 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 uson LinkedIn and Instagram.

JOB SUMMARY:

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Lead routine pharmacovigilance activities for a product or group of products, including aggregate data evaluation, signal detection and assessment, lead signal management process (i.e., signal tracking, review meetings, etc.).
• Prepare, author, and lead to completion the aggregate safety reports for assigned products, such as PSURs, PBRERs, DSURs, Pharmacovigilance Plans and Risk Management strategy and Plans.
• Collaborate with the Medical Director(s) in GDSP to ensure that all safety documentation is accurate and available to meet global compliance and regulatory requirements.
• Author signal evaluation reports, or sections of signal evaluation reports.
• Provide review of clinical protocols and study reports to ensure safety is addressed appropriately.
• In collaboration with the Medical Director(s), GDSP, lead safety contributions to the safety section of the Investigator's Brochure (IB)/Company Core Data Sheet.
• Contribute to regulatory authority submissions (NDAs, MAAs, Variations) by reviewing safety data and preparing relevant sections of the submission.
• Participate in or provide input for Drug Safety Monitoring Boards, as necessary.
• Conduct literature review for safety information and interaction with other groups to obtain necessary data (i.e., Medical Affairs, Clinical Development).
• Author responses to safety questions from regulatory authorities for assigned products.
• Contribute to and lead initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions, and vendor management as required.
• Take active part in Departmental activities based on strong safety/PV experience and expertise; examples include SOP, Work Instruction development, etc.
• Represent GDSP on commercial launch teams and initial steering committees for partnerships. Continued GDSP representation with affiliates, partners, and vendors after launch.
• Responsible for drafting PVAs and driving them to finalization with all appropriate BioCryst business partners including foreign marketing authorization holders, distributors, development or marketing collaborators, individual investigators or entities leading clinical trials with BioCryst products.
• Establish and maintain tracking mechanism for all BioCryst PVAs within GDSP to support PVA Compliance and KPI management. Maintain and perform routine reviews of PVAs, updating as required.
• Contribute to development of the PV Systems by collaborating with cross-functional teams.
• Communicate and educate through all levels of the organization on PV activities required for commercialization and compliance with global GVP.
• Responsible for informing GDSP of new and updated PVAs and ensuring any necessary training.
• Responsible for review and input to PV sections of Quality Agreements and Distribution/Licensing Contracts.
• Collaborate with QA department to maintain a state of PV inspection readiness across all regions/countries.
• Participate in regulatory inspections and audits as a subject matter expert for affiliate and partner PV activities as well as Safety Science as required.
• Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• PhD, MSc, PharmD, BSN or BS degree with a minimum of 10 years' experience in Drug Safety and Pharmacovigilance required
• Knowledge of GVP, ICH-GCP, and global regulatory PV requirements
• Understanding of epidemiologic principles
• Ability to evaluate, interpret/synthesize scientific data (analytical thinking)
• Excellent writing and communication skills in English
• Ability to manage multiple projects, maintain timelines, and lead scientific teams as necessary
• Team player with ability to effectively represent PV in a multi-disciplinary environment
• Strong initiative, strong organizational and time management skills
• Basic knowledge of common data processing software (Microsoft Excel, PowerPoint, Word, Business Objects)
• Knowledge of common safety database systems (e.g., Argus)
• Working knowledge of medical affairs and pharmaceutical commercial processes, promotional activities and patient support activities
• Experience in developing and managing Pharmacovigilance Agreements is preferred. Experience with other contractual agreements and Scopes of Work is also beneficial

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.