Novartis Gene Therapies Director, Medical Safety, Global Patient Safety in Bannockburn, Illinois
Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.
The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.
We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.
Novartis Gene Therapies is seeking a Director, Medical Safety to act as a drug safety medical expert responsible for clinical safety and risk management for assigned products as well as medical assessment of individual adverse event reports, generation and review of aggregate reports and management of safety signals from clinical program and post-marketing. The Director Medical Safety will lead the safety management team for assigned products and be responsible for the assessment of clinical safety and benefit-risk profiles across the product life cycle.
Must be a self-starter with drug safety expertise in early and late stage clinical development programs looking to be part of an innovative and fast-paced team supporting the company’s drug development activities.
Review all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post-marketing for assigned products.
Conduct safety signal detection activities, monitoring, evaluation, interpretation, management and communication.
Chair the cross-functional Safety Management Team for assigned products.
Collaborate with the clinical team, vendor and CRO safety physicians, medical monitors, toxicology group, and other functional groups in the identification, analysis, and reporting of possible safety signals.
Contribute to the development and maintenance of the product safety profile. Provide medical safety input into all critical documents (e.g. protocols and amendments, IBs, CSRs, submission dossiers, INDs, BLAs).
Track events of special interest and assist in development and maintenance of standardized queries for events of special interest.
Develop the strategy for analysis in support of responses to regulatory, DSMB, IRBs and Investigators or ad hoc inquiries regarding safety issues.
Develop the strategy and analysis plan for periodic reports.
Draft regulatory inquiry responses and provide oversight on key content of risk management documents (RMPs, REMs) and aggregate reports.
Participate in regulatory meetings, interactions and submission activities as necessary.
M.D. with 3-5 years of clinical experience.
Clinical experience in relevant areas (e.g. pediatrics, neurology) desired.
Minimum 5 years of experience in the pharmaceutical industry, predominately in drug safety, having worked on both clinical development and marketed products.
Clinical development and/or drug safety experience with biologics, gene therapy products desirable.
Credible knowledge of global regulations governing Pharmacovigilance for products in clinical development and post-marketing.
Effective multi-tasking skills applied in different and complex assignments and ability to work effectively under pressure and under strict timelines.
Ability to work both independently and collaboratively.
Approachable, flexible and self-motivated..
Open to changes, suggestions and innovations, continuously on the look-out for work process improvements.
Occasional travel (up to 15%) for conferences, meetings and professional development activities.
The level of this position will be based on the final candidate’s qualifications.
Novartis Gene Therapies Benefit Summary:
Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and employee recognition scheme are some of the benefits you will receive as an employee of Novartis Gene Therapies.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Job Locations US-IL-Bannockburn
Posted Date 1 day ago (1/13/2021 3:15 PM)
Job ID 2021-5834
# of Openings 1
Category Global Patient Safety
Novartis Gene Therapies
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