Patient Safety Lead

Primary Duties

Reporting to the Head of Pharmacovigilance, the Pharmacovigilance (“PV”) Patient Safety Lead will collaborate closely with the Head of PV to ensure Spark protects patients’ safety by providing safety support for products in various stages of clinical development and following them through their lifecycle and commercialization. S/he will serve as the medical safety lead for PV activities aligned to the strategy, goals and objectives of the Pharmacovigilance function in compliance with company goals and objectives, and requisite global and local regulations and requirements.

Responsibilities

Clinical safety:

• Serve as the PV representative on the product development team and collaborate with partner clinical safety lead if applicable for safety data collection and safety related issues
• Author or review the safety portion of IB, protocols, ICFs, and CSRs
• Conduct periodic safety data review (eg. labs, and AE data)
• Perform coding review and approval if applicable
• Liaise with clinical study teams and/or medical monitor to oversee safety monitoring of clinical trials

Signal detection and risk management:

• Perform ongoing review of emerging safety data from all sources
• Conduct routine safety signal detection
• Manage and lead Safety Review Team meetings
• Ensure that all significant safety signals or safety issues are tracked, escalated if required, and addressed appropriately
• Lead the planning and development of PV risk management activities throughout product development, commercialization, and post-marketing commitments

Aggregate reporting:

• Lead the preparation of DSUR/PBRER including setting up strategy and timelines with key stakeholders and vendors, authoring relevant safety sections, coordinating deliveries from each functional area

ICSR medical review

• Approve seriousness and expectedness assessment
• Conduct ongoing medical review for all ICSRs by creating/reviewing/approving company comments

Process development and training:

• Author and review departmental procedures and maintain audits and inspection readiness
• Train employees in overall pharmacovigilance and adverse event reporting

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

MD/DO or equivalent with generally 4 years of clinical practice experience; exposure to rare disease management, hematology, or CNS diseases preferred, but not required Generally, 4+years of relevant drug development experience; Pharmacovigilance / drug safety serving in a PV scientist or safety physician role (both pre- and post-marketing experience) in a pharmaceutical / biotechnology company or CRO preferred Experience in drug safety databases, individual case processing, and MedDRA and WHO-DD coding Experience in aggregate reporting, signal detection, and risk management is preferred

Key Skills, Abilities, and Competencies

Thorough understanding of ICH-GCP, cGMP, FDA, EMA, and other regulatory requirements pertaining to 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 inspire confidence and work successfully with varied audiences Demonstrated strength with organizational management, leadership and team-building

#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.