Medical Director, Global Drug Safety & Pharmacovigilance

Role Summary

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 Medical Director is responsible for ongoing safety surveillance, signal detection and management, medical review of cases, and for providing pharmacovigilance and safety assessment expertise to clinical and regulatory teams.

Responsibilities

• Provide safety input and or author sections of regulatory documents such as IND/NDA submissions, MAAs, Product Labeling and promotional materials.
• Contribute to the development of clinical research documents including Protocols, Informed Consent Forms, training materials, Study Manuals, Guidelines, etc.
• Provide support to clinical development teams regarding emerging benefit-risk profile, appropriate safety monitoring during clinical trials and safety strategy for drugs in development
• Provide medical and safety input and or author select sections of the Clinical Study Reports, internal and external presentations, and briefings on safety.
• Contribute to the development and implementation of safety review processes for assigned products, to ensure ongoing risk/benefit assessment of all products.
• Contribute to the development and implementation of safety activities for post-marketing products, including Post-marketing (PM) Surveillance Programs, Risk Evaluation and Mitigation Strategies (REMS) when required.
• Contribute to post-marketing surveillance and analysis on assigned products.
• Prepare and review aggregate safety reports (e.g., DSUR, PBRER), PSMF as applicable, and selected clinical documents including regulatory filings and risk management plans.
• Lead evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation. Prepare and Review reports on safety signals (i.e., Safety Topic Reviews/ Signal Reports) and ad hoc regulatory responses.
• Responsible for the medical review of all sources of safety information including ICSRs, product complaints, and requested medical information queries.
• Contribute to safety labeling activities for BioCryst products and ensure safety labeling adequately reflects emerging post marketing safety profile.
• Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
• Serve as BioCryst safety lead on assigned projects with Business Partners, Vendors, Clinical Development Teams and Post Marketing Project Teams and in interactions with Medical Monitors and other BioCryst
• Maintain current knowledge and understanding of regulations, ICH guidelines and industry practices in relation to pharmacovigilance.
• Attend product team meetings, safety team meetings, company safety governance meetings, and regulatory interactions. Some travel may be required for safety meetings with colleagues, partners, vendors, and regulatory authorities, and for attendance at conferences.
• Other duties as assigned.

Qualifications

• MD or equivalent, with at least 5 years of Drug Safety experience required
• Knowledge of GVP, ICH-GCP, and regional regulatory PV requirements
• Critical thinker and strong interpersonal skills
• Excellent writing and oral communication skills in English
• Ability to work with others at all levels and from a wide range of backgrounds in the company (including internal and external), able to lead through influence
• Ability to manage multiple projects and maintain timelines.
• Competence with standard office computer software tools.

Skills

• Pharmacovigilance and safety data analysis
• Regulatory writing and submissions
• Medical review of safety information and reports
• Risk management planning and REMS oversight
• Cross-functional collaboration and leadership
• Signal detection and risk/benefit assessment