COMPANY:
At BioCryst, we are passionate about advancing novel therapeutics for patients with rare and serious diseases. Our structure-guided drug design process leads us to the discovery and development of novel small-molecule drugs. We integrate traditional biology and medicinal chemistry along with a wide array of advanced technologies to understand the three-dimensional structures of active sites of target enzymes. Our scientists then design molecular structures to create bespoke drugs for patients. We focus on therapeutic areas with either no available treatments or large unmet patient needs. BioCryst’s US headquarters are located in Durham, North Carolina, our European headquarters in Dublin, Ireland and our Discovery Center of Excellence in Birmingham, Alabama. 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 the Company’s website at www.biocryst.com.
JOB SUMMARY:
Reporting to the SVP of GDSP, the Medical Director, GDSP and deputy QPPV (dQPPV) 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.
In addition to their individual contributor role as a medical director, they will be designated the dQPPV and will assist the EU QPPV in the management and maintenance of the global Pharmacovigilance System at BioCryst. They must reside in the EU and be continuously available when taking over QPPV duties. The EU dQPPV will have direct and immediate access to the QPPV and they will be empowered to raise any issues or concerns to the Global Safety Committee. The EU dQPPV will be an integral member of the signal management team and represent the QPPV as needed on the Global Safety Committee and to GDSP leadership.
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 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.
Provide medical support to 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.
Participate 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.
EU dQPPV specific responsibilities
Act as pharmacovigilance’s single point of contact for the EU Competent Authorities, the UK authority, and European Medicines Agency (EMA) on a 24 hour/7 day a week basis when acting as the QPPV
Assists the EU QPPV in oversight and management of the PV System that covers all products with a marketing authorization in the European Union (EU) and the UK
Assists the EU QPPV in ensuring an accurate benefit-risk assessment of all products marketed in the EU is reflected in correct and complete data submitted to European authorities including the EMA, PRAC and national CA.
Assists in the pharmacovigilance aspects of all product recalls or DHCP communications in the EU and UK
EXPERIENCE & QUALIFICATIONS:
MD or equivalent, with a minimum of 3 years of pharmacovigilance experience required. If candidate does not have pharmacovigilance experience, must have at least 4 years of pharmaceutical experience in scientific area such as clinical development, regulatory or medical affairs
Reside in the EU and meet all requirements for registration as an EU QPPV
Expert knowledge of EMA safety regulation, GVP, ICH Guidelines, and other applicable regulatory requirements and guidance documents including FDA safety regulations; expertise in global pharmacovigilance regulations.
Expertise in clinical safety assessments, safety signal detection and risk management, Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
Highly self-motivated with a demonstrable passion for pharmacovigilance and strong interpersonal skills
Ability to present and critically discuss clinical data in both internal and external discussions including interactions with regulatory authorities
Ability to work with cross function safety teams and global safety teams (internal and involving business partners)
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.