Director, Safety Science & PV Vendor Oversight

COMPANY Bio Cryst

Bio Cryst is committed to improving the lives of people living with complement-mediated and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics. Our Discovery Center of Excellence is in Birmingham, Alabama, with global headquarters in Durham, North Carolina and a worldwide team across multiple sites. We foster a culture of engagement and accountability that rewards innovative thinking and achievement of key objectives.

For more information, please visit  or follow us on Linked In and Instagram.

Accountable for scientific leadership in pharmacovigilance and drug safety activities for assigned clinical studies, drug product development, and the post-marketing setting. Responsible for leading ongoing safety surveillance, signal detection and management, and for providing pharmacovigilance and drug safety expertise to clinical and regulatory teams. Oversees affiliate and partner activities related to pharmacovigilance regulations for Bio Cryst products. Represents GDSP on internal launch or steering teams, drafts and drives pharmacovigilance agreements (PVAs) with affiliates, distributors, and licensing partners, and provides global pharmacovigilance support for Bio Cryst affiliate offices as required.

Keeps GDSP informed of potential market expansions and product distribution plans. Ensures affiliates, pharmacovigilance partners, and distributors comply with global adverse event reporting requirements.

• Lead routine pharmacovigilance activities for a product or group of products, including aggregate data evaluation, signal detection and assessment, and lead signal management processes (e.g., signal tracking and review meetings).
• Prepare, author, and lead to completion 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 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 coordinate with Medical Affairs and Clinical Development to obtain necessary data.
• 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.
• Participate in departmental activities based on strong safety/PV experience and expertise (e.g., SOP and Work Instruction development).
• Represent GDSP on commercial launch teams and initial steering committees for partnerships, with continued representation with affiliates, partners, and vendors after launch.
• Draft PVAs and drive them to finalization with Bio Cryst business partners including foreign marketing authorization holders, distributors, development or marketing collaborators, and investigators or entities leading clinical trials with Bio Cryst products.
• Establish and maintain a tracking mechanism for all Bio Cryst PVAs within GDSP to support PVA compliance and KPI management. Review PVAs periodically and update as required.
• Contribute to development of PV Systems by collaborating with cross-functional teams.
• Educate the organization on PV activities required for commercialization and compliance with global GVP.
• Inform GDSP of new and updated PVAs and ensure any necessary training.
• Review and provide input to PV sections of Quality Agreements and Distribution/Licensing Contracts.
• Collaborate with QA to maintain PV inspection readiness across 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.

• PhD, MSc, Pharm
  
  D, BSN or BS 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, and synthesize scientific data (analytical thinking)
• Excellent writing and communication skills in English
• Ability to manage multiple projects, maintain timelines, and lead…