Pharmacovigilance Safety Scientist
- Employer
- Spark Therapeutics
- Location
- Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
- Salary
- Salary not provided
- Closing date
- Jun 2, 2022
View more
- Discipline
- Health Sciences, Drug Development
- Job Type
- Staff Scientist
- Organization Type
- All Industry, Pharma
Job Details
Job Function and Description
Clinical Development:
- Represent PV during internal cross-functional and external vendor meetings
- Provide input to clinical development planning activities
- Liaise with colleagues across functions to support collaborative workflows
Clinical Safety
- Proactively review clinical safety data to maintain current understanding of trial findings
- Responsible for performing database searches, and analyzing/interpreting clinical trial data
- Support PV patient safety lead during cross-functional document authorship (CSR, IB, protocol, ICF, etc.) including responses to health authority queries
Pharmacovigilance:
- Coordinate authorship of aggregate reports (DSUR, PSUR), ensuring high-quality and timely submissions
- Interpret data to support product safety surveillance and signal detection activities, partner queries, and health authority requests
- Support internal PV audits, regulatory inspections, updates to safety management plans, Sponsor training materials, and SOPs
- Maintain a central repository of drug safety documents, including records of signal detection and other PV activities pertinent to regulatory inspections
- Foster Spark’s Culture. Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
- Develop people. Understand each individual team member’s career goals. strengths and motivators. Partner with your team members to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning and stretch opportunities.
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Advanced science degree (eg. Pharm.D., Ph.D., MPH/MS)
5+ years of pharmacovigilance and/or clinical trial experience
Knowledge of related disciplines preferred (eg. Epidemiology, biostatistics, or pharmacology)
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Familiarity with ICH-GCP, cGMP, FDA, EMA, and other regulatory requirements pertaining to clinical trial design, conduct, adverse event assessment and reporting, risk management, and post-marketing safety requirements
Ability to analyze and interpret medical and scientific data
Demonstrated scientific writing skills
Ability to manage multiple priorities and work in a flexible, dynamic and fast-paced environment
Excellent written and oral communication, influence, and project management skills, with the ability to work successfully across functions
Track record of building consensus and driving collaborative documents to completion
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
Nearest Major Market: Philadelphia
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.
Company
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.
Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.
- Website
- http://sparktx.com/
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