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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
Pharma
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Job Details

Primary Duties

Reporting to the Pharmacovigilance (“PV”) patient safety lead, the PV safety scientist will provide scientific expertise across clinical development programs. S/he will collaborate closely with the PV patient safety lead to support candidates/products in various stages of clinical development and commercialization. The PV safety scientist will be a key member of the PV team, and will be aligned to the strategy, goals, and objectives of the PV function. S/he will regularly collaborate across functions, and will represent PV in both internal meetings and external meetings with business partners.

Responsibilities

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

Collaborate with other functional area to achieve business goals and objectives.

  • 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.
Education and Experience Requirements

    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)

Key Skills, Abilities, and Competencies

    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
#LI-Hybrid

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.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
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