JOB SUMMARY:
The Medical Director, Global Drug Safety & Pharmacovigilance (GDSP) will work in tandem with the Senior Medical Director, GDSP to implement and coordinate safety surveillance procedures for BioCryst products. Responsibilities include formulating safety surveillance policies and procedures with management input as necessary; monitoring the safety profile of assigned products and leading product reviews at the regular signal detection meetings; interpreting the medical significance of incoming safety information; preparing assigned regulatory and ad hoc safety reports; serving as the BioCryst safety science lead to Clinical Development Teams and business partners on assigned projects; and overseeing the activities of other Drug Safety personnel. The Medical Director, GDSP will also participate in departmental initiatives for the development of pharmacovigilance best practices, acting as safety representative in company initiatives and mentoring junior or non-medical drug safety colleagues.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Develop & lead safety activities and benefit-risk strategies throughout the life cycle for assigned BioCryst products in post-marketing, clinical development or both
- Oversee, prepare, contribute, and/or review aggregate safety review documents (e.g., DSUR, PBRER), PSMF and selected clinical documents including regulatory filings and risk management plans
- Lead evaluation and management of signals emerging from any data source. Develop strategy for signal evaluation. Prepare and review Signal Evaluation Reports (SERs) and ad hoc regulatory responses.
- Presentation of safety signals to the development team and Global Safety Committee
- Responsible for the medical review of all sources of safety information including ICSRs, product complaints, and requested medical information queries for assigned products.
- Contribute to safety labeling activities for BioCryst products and ensure safety labeling adequately reflects emerging post marketing safety profile.
- Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
- Provide support to clinical development teams regarding emerging benefit-risk profile, appropriate safety monitoring during clinical trials and safety strategy for drugs in development.
- Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
- Act 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 personnel.
- Participate in company initiatives as a drug safety representative.
- May oversee activities delegated to other personnel.
- Mentor junior drug safety personnel, including drug safety scientists.
- Participation as required in internal audits and Health Authority inspections
- Maintain current knowledge and understanding of regulations, ICH guidelines and industry practices in relation to pharmacovigilance.
- Attend product team meetings as needed, safety team meetings, company safety governance meetings, and regulatory interactions. Some travel may be required for safety meetings with partners, vendors, and regulatory authorities, and for attendance at conferences.
EXPERIENCE & QUALIFICATIONS:
- MD or equivalent, with a minimum of 3 years of pharmacovigilance experience required. If a candidate does not have pharmacovigilance experience, must have at least 4 years of pharmaceutical experience in a scientific area such as clinical development, regulatory or medical affairs
- Knowledge of GVP, ICH-GCP, and regional regulatory PV requirements
- Experience in signal detection and analysis processes
- Ability to work with cross function safety teams and global safety teams (internal and involving business partners)
- Vendor management experience a plus
- Critical thinker and strong interpersonal skills
- Self-motivated with strong problem-solving skills
- Excellent written and oral communication in English
- Ability to work with others at all levels and from a wide range of backgrounds in the company (incl. internal and external), able to lead through influence
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.