Sr. Manager, Drug Safety Scientist

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, our European headquarters is in Dublin, Ireland 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 us on LinkedIn and Instagram.

 

JOB SUMMARY:

Reporting to the SVP, GDSP, the key focus of the Sr. Manager, Drug Safety Scientist role is on drug safety, evaluation, and risk-management. You will lead the safety scientists in developing signal detection practices and provide leadership for both the GDSP group and external departments regarding signal detection, signal evaluation and risk management. Day-to-day, you will be responsible, in conjunction with the assigned medical director, GDSP, for monitoring and evaluating safety profiles for allocated products. Coordination and administration of the signal detection team and all supporting documentation will be managed by the Sr. Manager, Drug Safety Scientist. Safety science will focus on post-marketing data but will include clinical development molecules as required.  #LI-Remote

 

ESSENTIAL DUTIES & RESPONSIBILITIES:

• The Sr. Manager, Drug Safety Scientist, in conjunction with the assigned product Medical Director GDSP, is responsible for developing fit-for-purpose and appropriate signal detection strategies for assigned products, utilizing various techniques and detection thresholds based on the molecule characteristics (life-cycle, indication, population, risk profile, etc),
• The Sr. Manager, Drug Safety Scientist partners with the assigned product Medical Director GDSP and will ensure that all safety documentation is accurate and meets global compliance and regulatory requirements.
• Develops and maintains an understanding of the safety profile of assigned product(s) and understand the indication disease background and epidemiology
• Leads the preparation and authoring of aggregate safety reports for assigned products, such as PSURs, PBRERs, DSURs, Pharmacovigilance Plans and Risk Management strategy and Plans.
• Facilitates signal management processes for assigned products (i.e., signal tracking, leading review meetings, etc.) and in collaboration with the Medical Director, GDSP, evaluates safety data and signals as part of ongoing pharmacovigilance activities.
• Authors signal evaluation reports (SERs), or sections of SERs. May review SERs written by more junior safety scientists.
• May review clinical protocols and study reports to ensure safety risk is adequately addressed.
• Contributes to the safety section of the Investigators Brochure (IB).
• Contributes to regulatory authority submissions (NDAs, MAAs, Variations) by reviewing safety data and preparing relevant sections of the submission.
• Conducts or oversees literature reviews for safety information
• Maintains compliance with PVAs regarding exchange of signal or urgent safety information.
• Interacts with other groups to obtain necessary safety related data (i.e., Medical Affairs, Clinical Development).
• Authors or reviews responses to safety questions from regulatory authorities for assigned products.
• Presentation of safety findings to safety teams, product teams and the Global Safety Committee or other leadership committees as needed
• Leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
• Provides Safety science leadership in departmental activities, including PSMF maintenance, PVA preparation, SOP development, etc.

 

 

EXPERIENCE & QUALIFICATIONS:

• Life-science degree such as PhD in scientific field, pharmacy degree, MS or BS