Senior Safety Scientist - Durham, NC | Biospace
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Senior Safety Scientist

BioCryst Pharmaceuticals, Inc.

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Location:
Durham, NC
Posted Date:
8/30/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Drug Safety, Pharmacovigilance, Senior Scientist,

Job Description


Essential Duties and Responsibilities

The Senior Safety Scientist is responsible for carrying out pharmacovigilance , drug safety and risk management activities for assigned products. This may include medical single case review, aggregate reporting, signal detection and evaluation, safety related activities associated with new drug applications and other regulatory filings, risk benefit evaluation and safety risk management, and contributing safety sections to supporting regulatory documents.

Post-marketing pharmacovigilance

•   Develop and implement Pharmacovigilance and Risk Management planning for designated products by preparation of the safety surveillance strategy, and tracking and evaluating potential issues
•   May include responsibility for the development and execution of RMP or REMS risk mitigation activities
•   Preparation of periodic aggregate safety reports (PBRER / PSUR, DSUR, EU renewal and other Annual Safety Reports) in accordance with regulatory requirements and standard operating procedures
•   Preparation and maintenance of safety sections of the Company Core Data Sheet
•   Lead or support post-marketing safety study activities
•   Respond to safety requests for the assigned products from regulatory agencies
•   Support all relevant compliance activities including implementation of assigned CAPAs

Safety signal detection

•   Conduct/support signal detection and evaluation according to SOPs and guidelines
•   Carry out medical review of individual case safety reports (ICSRs), for assigned products according to SOPs and guidelines
•   Prepare safety assessments and drug safety reports, as necessary, for potential signals or product quality issues
Clinical pharmacovigilance (clinical safety)
•   Provide safety content of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with the clinical development plan
•   Contribute to regulatory authority submissions (INDs, NDAs, MAAs, Variations, Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages
•   Participate in and provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings for assigned products
•   Develop an understanding of the safety profile of the assigned product

Requirements


REQUIRED EDUCATION/EXPERIENCE/SKILLS:

•   PhD, PharmD, Pharm, MS, MPH, MD, RN, BS Nursing
•   5+ years experience in pharmaceutical safety including a thorough understanding of case processing and other pharmacovigilance processes
•   Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; expertise in global safety regulations.
•   Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities
•   Demonstrated ability to solve problems with innovative solutions along with strong organizational skills
•   Effective team player, fosters collaboration within and across functional areas.
•   Sound strategic evaluation, analysis, and decision-making skills
•   Able to handle pressure in a dynamic, fast paced environment.
•   Expert oral and written communication of complex scientific topics, data and analyses
•   Effective and efficient internal oral and written communication
•   Excellent interpersonal skills, with ability to rapidly form and grow productive peer relationships with colleagues across different disciplines
•   Ability to understand, influence and work in a multicultural atmosphere
•   Teamwork, responsiveness, creativity, initiative
•   Planning, reporting, and follow-up
•   Efficient utilization of standard computer software essential in the modern office

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 laws.

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.