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
- 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
- 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
- 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.
Education and Experience Requirements
- 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.
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
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:
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