Safety Scientist CONTRACT

JOB SUMMARY:

Reporting to the VP, GDSP, the key focus of the Safety Scientist role is on drug safety, 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 Safety Scientist. Safety science will be responsible for assessing the benefit-risk of assigned products, with a focus on post-marketing safety and safety risk management but may include clinical development molecules as required. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• The 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 Safety Scientist partners with the assigned product Medical Director, GDSP and will ensure that all safety documentation is accurate and available to meet global compliance and regulatory requirements.
• Develop and maintain an understanding of the safety profile of assigned product(s) and understanding the indication disease background and epidemiology
• Collaborates on 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 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 reviews literature reviews for safety information
• Interacts with other groups to obtain necessary safety related data (i.e., Medical Affairs, Clinical Development).
• Contributes to 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
• Contributes to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
• Assists in Departmental activities depending on experience and expertise. Examples include PSMF maintenance, PVA preparation, SOP development, etc.

EXPERIENCE & QUALIFICATIONS:

• Life-science degree such as PhD in scientific field, pharmacy degree, MS or BS in scientific field, MPH, BS Nursing
• Minimum of 5 years in pharmacovigilance in a pharmaceutical or biotech environment required, with a thorough understanding of signal detection and assessment
• Strong knowledge of global PV regulations, particularly European regulations
• Good knowledge of GVP practices
• Understanding of epidemiologic principles
• Highly self-motivated with a demonstrable passion for pharmacovigilance and strong interpersonal skills
• Excellent written English skills
• Ability to present and critically discuss clinical data in both internal and external discussions
• Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
• Team player with ability to function in a multi-disciplinary environment
• Basic knowledge of common data processing software (Microsoft Excel, PowerPoint, Word, Business Objects)
• Knowledge of common safety database systems (e.g., Argus) and ability to write accurate database queries for signal detection activities

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.