Director - Senior Director, Pharmacovigilance Operations

February 28

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Scholar Rock

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Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Our most advanced investigational product candidate, apitegromab (SRK-015), a

51 - 200 employees

Founded 2016

💰 $205M Post-IPO Equity on 2022-06

📋 Description

•Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. •As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. •Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. •Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). •This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. •By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. •Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn. •The Director/Sr Director of Pharmacovigilance (PV) Operations is the lead point of contact and accountable for PV Operations. •Responsible for directing the day-to-day activities including planning, oversight and management of vendors, business partners, contracting for Individual Case Safety Report (ICSR) activity, to ensure efficiency, quality, and compliance with internal procedures and global regulations. •Responsible for directing study start up, conduct and close-out, PV compliance, and operational budget oversight of PV vendors and systems. •Establishes compilation of metrics, supports department meetings and functional lead for study teams and collaborates on the support of risk management and PV activities for all Scholar Rock products. •Leads safety vendor planning, and execution of process improvements, procedures, and solutions related to Scholar Rock PV, ICSR and Aggregate reporting.

🎯 Requirements

•Bachelor’s degree or Nursing equivalent (preferably in a science or health-related field) and a masters preferred •A minimum of 7 years of experience in PV Operations •Strong working knowledge of PV regulations and PV processes •Proficiency with standard desktop computing programs (e-mail, Word, Excel, PowerPoint) and relational databases •Experience of Oracle Argus Safety is preferred •Excellent Project Management, oral/written/interpersonal skills, results oriented and strong attention to detail •Ability to manage multiple, complex projects in a fast-paced environment with capacity to prioritize, plan and organize work assignments under strict timelines •Able to be diplomatic, tactful and detail-oriented with exceptional critical reasoning skills. Able to deal with ambiguity and demonstrate a creative and pragmatic approach to problem solving.